Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Caelyx® administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.

Caelyx®

Elisabetta Munzone, MD

A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer.

The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.

Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.

In the 2011 St Gallen Consensus Conference, the Panel considered that both anthracyclines and taxanes should be included in the chemotherapy regimen for 'Luminal B' disease1. However, several patients are reluctant to receive a "strong" chemotherapy because of the fear of its toxic effects, and usually ask for a somehow "less intensive" approach, even accepting a possible reduction in the treatment efficacy.

One of the reasons why patients refuse chemotherapy more often is the fear of alopecia. Few dermatologic conditions carry as much emotional distress as chemotherapy-induced alopecia. Hair loss negatively affects a patient's perception of appearance, body image, sexuality, and self- esteem.

We decided to conduct a single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer.

The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment.

Secondary endpoints will include:

* Adverse events
* Tolerability (treatment completion)
* Breast cancer free interval (BCFI; events are reappearance of invasive breast cancer at any site including contralateral disease)
* Disease Free Survival (DFS) (includes second malignancies and deaths)
* Overall survival (OS) Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.

CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER

CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer: a Feasibility Phase II Trial

The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment

Grading for all side effects will be according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

percent of patients treated according to the protocol and completing the adjuvant program, and percent protocol treatment received

BCFI is defined as the time from registration to local (including recurrence restricted to the breast after breast conserving treatment), regional, or distant relapse, or contralateral breast cancer.

DFS is defined as the time from registration to disease recurrence (includes second malignancies and deaths)

OS defined as the time from registration to death from any cause

Janssen-Cilag International NV

European Institute of Oncology

Symptoms and General Pathology

Carcinoma

Neoplasm Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

An intratumoral insertion of radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Aleksandr Obukhov

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for newly Diagnosed Breast Carcinoma patients with distant metastases

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive sources \[Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)\] inserted into malignant breast lesions.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Histopathological confirmed invasive breast tumors with no involvement of skin will be treated using DaRT seeds.

The primary effectiveness endpoint of the study is the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 9-11 weeks after DaRT seed insertion.

Safety will be assessed by the cumulative frequency, severity and causality of acute adverse events related to the DaRT treatment of adverse events (AEs) observed including the follow-up period.

Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases

Assessment of the rate of malignant breast tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).

Assessment of the frequency, severity and causality of acute adverse events related to the DaRT treatment using the Common Terminology and Criteria for adverse events (CTCAE) version 5.0

Assessment of the reduction in tumor volume SUVmax based on CT/PET - CT measured tumor volume.

Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging.

Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires EORTC-QLQ-C30. Scale range in score from 0 (best) to 100(worst).

Time elapsed from response to disease progression.

Assessment of (complete) pathological remissions using histopathology examination

Assessment of abscopal effects on existing distant metastases based on PET-CT measured tumor volume.

Assessment of patient reported health-related Quality of Life (QoL) outcomes after DaRT treatment, using QoL questionnaires BR23. Scale range in score from 0 (best) to 100(worst).

Assessment of abscopal effects on existing distant metastases based on PET-CT measured SUVmax decrease compared to the primary measurement (the baseline measurement).

Alpha Tau Medical LTD.

Antirheumatic Agents

Antibodies

Paclitaxel

Cyclophosphamide

Albumin-Bound Paclitaxel

Durvalumab

Immunoglobulins

Antineoplastic Agents, Immunological

The combination of weekly paclitaxel 80 mg/m² IV followed by q2w dose-dense doxorubicin-cyclophosphamide (ddAC) (60 mg/m² doxorubicin IV and 600 mg/m² cyclophosphamide IV) and pre-operative radiation therapy on the primary tumour (3x8 Gy).

The combination of weekly paclitaxel 80 mg/m² IV followed by q2w dose-dense doxorubicin-cyclophosphamide (ddAC) (60 mg/m² doxorubicin IV and 600 mg/m² cyclophosphamide IV) and pre-operative radiation therapy on the primary tumour (3x8 Gy) with the addition of the anti-PD-L1 antibody durvalumab IV 1500 mg q4w.

The combination of weekly paclitaxel 80 mg/m² IV followed by q2w dose-dense doxorubicin-cyclophosphamide (ddAC) (60 mg/m² doxorubicin IV and 600 mg/m² cyclophosphamide IV) and pre-operative radiation therapy on the primary tumour (3x8 Gy) with the addition of the anti-PD-L1 antibody durvalumab IV 1500 mg q4w and the addition of the anti-CD73 antibody oleclumab IV 3000 mg q2w for 4 administrations, followed by q4w for 3 administrations.

an anti PD-L1 intravenous administration at 1500 mg every 4 weeks for 19 weeks.

Pre-operative radiation therapy (boost dose) 3x8 Gy on the primary tumour at week 5 given in 3 fractions. The 3 fractions will be spread at the minimum over 3 days and at the maximum over 6 days.

Stereotactic Body Radiotherapy

an anti-CD73 intravenous administration at 3000 mg every 2 weeks for the first 4 administrations then every 4 weeks for the last 3 administrations.

Oleclumab

Alex De Caluwe, MD

Neo-CheckRay is a multicenter, open-label phase II study that randomizes luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy in a 1:1:1 ratio in 3 arms:

1. the combination of weekly paclitaxel followed by dose-dense doxorubicin-cyclophosphamide (ddAC) and pre-operative radiation therapy (boost dose) on the primary tumour
2. arm 1 with the addition of the anti-PD-L1 antibody durvalumab
3. arm 2 with the addition of the anti-CD73 antibody oleclumab The primary tumour will be excised 2-6 weeks after completion of ddAC. A safety run-in is planned for the 6 first subjects before starting the randomized phase II trial. Those 6 subjects will receive the treatment given in Arm 3.

This trial consists of a safety run-in followed by a phase II randomised trial. The goal of the safety run-in is to assess the safety of adding SBRT to the neo-adjuvant systemic treatment. The doses of the IMPs will be identical in the safety run-in and the phase II randomised trial. Individual subject timelines are also identical in the safety run-in and the phase II randomised trial.

The safety run-in is done as a precursor to the phase II randomised part of the Neo-CheckRay trial. Six subjects will be included in the safety run-in. These subjects are not part of the phase II total recruitment.

Subjects in the safety run-in will receive the following treatments corresponding to arm 3 of the phase II randomised trial. This consists of:

* q1w paclitaxel 80 mg/m² IV for 12 administration (12 weeks) followed by q2w dose-dense doxorubicin-cyclophosphamide IV (60 mg/m² and 600 mg/m² respectively) for 4 administrations (8 weeks)
* Anti-PD-L1 antibody durvalumab 1500 mg IV q4w for 5 administration (20 weeks)
* Anti-CD73 antibody oleclumab 3000 mg IV q2w for 4 administrations (8 weeks), followed by q4w for 3 administrations (12 weeks)
* Pre-operative radiation therapy (boost dose) 3x8 Gy on the primary tumour at week 5

If all requirements are meet during the safety run-in, then the phase II part of the study will be opened. The phase II will consist of luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy will be randomised in a 1:1:1 ratio between 3 arms:

1. Arm 1: the combination of weekly paclitaxel 80 mg/m² IV followed by q2w dose- dense doxorubicin-cyclophosphamide (ddAC) (60 mg/m² doxorubicin IV and 600 mg/m² cyclophosphamide IV) and pre-operative radiation therapy on the primary tumour (3x8 Gy).
2. Arm 2: drugs regimen of Arm 1 with the addition of the anti-PD-L1 antibody durvalumab IV 1500 mg q4w.
3. Arm 3: drugs regimen of Arm 2 with the addition of the anti-CD73 antibody oleclumab IV 3000 mg q2w for 4 administrations, followed by q4w for 3 administrations.

The primary tumour will be excised 2-6 weeks after completion of ddAC. The study treatments end at surgery. All treatment after surgery, such as post-operative radiotherapy and hormonal therapy, will be performed according to standard of care and local site guidelines. The patient will then be followed for the next 36 months (every 3 months during the first 24 months and every 6 months during the last 12 months).

Neo-CheckRay is a multicenter, open-label phase II study that randomizes luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy in a 1:1:1 ratio in 3 arms.

Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer:

Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer: a Phase ll Randomised Trial

Immune related or radiation therapy related toxicity of special interest are identifitied as:

* Any Grade 4 immune-related AE
* Any ≥ Grade 3 colitis
* Any ≥ Grade 3 renal failure/nephritis
* Any ≥ Grade 3 non-infectious pneumonitis irrespective of duration
* Any Grade 3 immune-related AE, excluding colitis, renal failure/nephritis and pneumonitis, that does not downgrade to ≤ Grade 2 within 3 days after onset of the event despite maximal medical supportive care including systemic corticosteroids or does not downgrade to ≤ Grade 1 or baseline within 14 days
* Liver transaminase elevation ≥ 5 ULN or total bilirubin \> 3 × ULN will be considered a DLT regardless of duration or reversibility
* Any increase in AST or ALT \> 3 × ULN and concurrent increase in total bilirubin \> 2 × ULN

Feasibility of performing surgery within 6 weeks after the last neo-adjuvant treatment. This would indicate that there were no significant delays or toxicities that would results in surgery being delayed.

To demonstrate improved tumour response of the primary tumour and nodal metastases in arms 2 or 3 versus arm 1 using residual cancer burden (RCB 0-1 vs. RCB 2-3) at time of surgery.

Complete pathologic response rate (pCR) of the primary tumour (ypT0), irrespective of the response rate of the resected nodal metastases

Complete pathological response rate (pCR) of the resected nodal metastases (ypN0), irrespective of the response rate of the primary tumour.

Calculation of the percentage of breast conservation surgery in arms 2 and 3 versus arm 1

Invasive Disease-Free Survival (iDFS) 3 years after surgery.

Duration and severity of AEs based on CTCAE 5.0.

Evaluation of the breast cosmetic changes using the independently validated Breast Cancer Conservative Treatment Cosmetic Results (BCCT.core) software (Cardoso et al., The Breast, 2007). Digitalized color photographs will be taken at multiple timepoints and the cosmetic changes will be scored quantitatively by the BCCT.core software program. The software performs an automatic calculation and attributes an overall cosmetic score: excellent, good, fair or poor (score 1-4; higher score means worse outcome).

Institut Curie

AstraZeneca

Jules Bordet Institute

Tubulin Modulators

Antimitotic Agents

Cabazitaxel 25 mg/m² i.v. (Day 1) every 3 weeks (cycle) as 1-hour i.v infusion for a total of up to 4 cycles over a maximum total treatment period of 15 weeks before surgery

Cabacitaxel

Paclitaxel 80 mg/m² as 1-hour i.v infusion. Patients will receive weekly (Days 1, 8, 15) paclitaxel administrations for a maximum of 12 infusions for a maximum of 4 cycles over a maximum total treatment period of 15 weeks before surgery (1 cycle = 3 weeks).

Gunter von Minckwitz, Prof. Dr.

Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel and was selected for development based on a better antiproliferative activity on resistant cell lines than docetaxel. It has shown superior survival against mitoxantrone (MTX) plus prednisone in docetaxel pre-treated hormone refractory metastatic prostate cancer patients leading to registration of the compound. It showed a favorable toxicity profile with an interestingly low rate of alopecia. In the Genevieve study it will be compared against weekly paclitaxel which is currently most widely used treatment of breast cancer patients. A head-to-head comparison in the neoadjuvant setting will allow a rapid and precise comparison of efficacy and tolerability of cabacitaxel versus paclitaxel to decide in how far further development of this taxoid in breast cancer is reasonable.

Primary Objective To compare the pathologic complete response (pCR) rate in the breast (ypT0/is ypN0/+) in patients with operable Triple Negative or luminal B/HER2 normal breast cancer treated with either cabazitaxel or weekly paclitaxel.

Secondary Objective To assess

* pCR rates per arm separately for the stratified subpopulations.
* Objective response rate (ORR) in the breast according to WHO criteria.
* pCR rate defined as ypT0 ypN0.
* pCR rate defined as ypT0/is ypN0.
* pCR rate in the axillary lymph nodes (ypN0).
* To determine the pCR rate and local recurrence free survival (LRFS) in patients with a clinical complete response (cCR) and a negative core biopsy before surgery.
* Breast conservation surgery rate.
* To assess the toxicity (NCI CTCAE V4.03) and compliance in both arms.
* Invasive loco-regional recurrence free survival (LRRFS), distant-disease-free survival (DDFS), invasive disease-free survival (IDFS), and overall survival (OS).
* To explore the biomarkers and profiles potentially predicting response to treatment.

Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)

Randomized, Open-label, Phase II Study Comparing the Efficacy and the Safety of Cabazitaxel Versus Weekly Paclitaxel Given as Neo-adjuvant Treatment in Patients With Operable Triple Negative or Luminal B/HER2 Normal Breast Cancer (GENEVIEVE)

pathologic complete response (pCR) rate separately for stratified subpopulations

To determine the pCR rate in patients with a clinical complete response (cCR) and a negative core biopsy before surgery

To determine the local recurrence free survival (LRFS) in patients with a clinical complete response (cCR) and a negative core biopsy before surgery

To assess the toxicity (NCI CTCAE V4.03) in both arms.

German Breast Group

Menopause

Vinorelbine

Hormones

Letrozole

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

* Oral Vinorelbine: 50 mg (30 mg + 20 mg) three times a week, for 3 weeks
* Letrozole: 2.5mg daily, for 3 weeks

Oral Vinorelbine: 50 mg (30 mg + 20 mg) three times a week, for 3 weeks

Metronomic Schedule of Vinorelbine administered orally in a schedule monday-wednesday-friday, tuesday-thursday-saturday, etc

Oral Vinorelbine

Letrozole will be administered orally at 2.5 mg QD for 3 weeks.

Aleix Prat, MD, PhD

VENTANA is a "window-of-opportunity" trial that will explore whether, similar to CDK4/6 inhibitors, Oral Metronomic Vinorelbine in combination with Letrozole induces a superior anti-proliferative effect than Letrozole alone.

VENTANA is a phase 0 multicenter, window of opportunity, three-arm, randomized clinical trial of oral metronomic vinorelbine (VNB) and letrozole versus either treatment alone in postmenopausal women with newly diagnosed untreated HR+ and HER2-negative, stage I-III operable breast cancer. Other eligibility criteria include primary tumor size 1 cm (cT1-3) and N0-1, ECOG PS 0-1 and evaluable diagnostic tumor sample.

Primary objective is to test if Oral Metronomic Vinorelbine and Letrozole induce a superior anti-proliferative effect than either drug alone in patients with early breast cancer defined as Luminal by PAM50/HER2-negative. This will be evaluated by measuring the expression of 11 proliferative genes contained in the PAM50/Prosigna® array (BIRC5, CCNB1, CDC20, CDCA1, CEP55, KNTC2, MKI67, PTTG1, RRM2, TYMS and UBE2C), as surrogate biomarker of its anticancer activity. By evaluating other breast cancer-related gene signatures (560 genes), the antiangiogenic and immunogenic potential of treatment arms will be compared and other genes regulated in a treatment-specific manner identified. These analyses will be performed in different PAM50-defined subtypes (Luminal, LuminalA or LuminalB). Clinical efficacy and safety of treatments will also be evaluated.

Patients will first undergo screening and mandatory collection of core tumor biopsies for study analysis. Patients are randomized (1:1:1) to receive Letrozole 2.5mg daily, oral Vinorelbine 50mg 3 days a week or Letrozole 2.5mg daily and oral Vinorelbine 50mg 3 times a week. After 3 weeks of treatment, patients will undergo surgery, and both pre-treatment and post-treatment surgery samples will be analyzed. Alternatively, if surgery will be delayed, a tumor core biopsy will be collected. Anyway, post-treatment sample should be collected within 5 days after end of treatment in order to observe the biological response.

Axillar and mammary surgery will be done according to local standards; however, sentinel lymph node biopsy previous to surgery is not permitted. Following surgical excision, adjuvant treatment will be as per investigator´s choice and local standards of care outside the scope of this protocol. End of study is 28 days (±3 days) after last study drug dose with a safety follow-up visit.

Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)

Randomized, Open-label, Three-arm, Parallel, Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole Versus Letrozole or Vinorelbine Alone in Post-menopausal Women With Hormone Receptor-positive HER2-negative Early Breast Cancer

* Outcome measure determined by following formula: Mean suppression of proliferation signature score = 100 - \[geometric mean (post treatment proliferation score/pre-treatment proliferation score · 100)\].
* Comparison of the Oral Metronomic Vinorelbine (VNB)+Letrozole arms versus VNB or Letrozole monotherapy arms in patients defined as Luminal by PAM50.

* Outcome measure determined by following formula: Mean suppression of proliferation signature score = 100 - \[geometric mean (post treatment proliferation score/pre-treatment proliferation score · 100)\].
* Comparison of the 3 treatment arms in the entire study population (evaluable patients defined as Luminal by IHC) and separately, in patients defined as either Luminal A or Luminal B by PAM50

Comparison of the 3 treatment arms in the entire PAM50-defined Luminal population (LuminalA+LuminalB) and separately, in the LuminalA or LuminalB subtypes.

* Expression data of breast cancer genes will be log base 2 transformed and normalized using 5 house-keeping genes
* Analysis will be performed in the entire PAM50-defined Luminal population (LuminalA+LuminalB) and separately, in the LuminalA or LuminalB subtypes.
* Aim of this outcome measure is to identify those genes with a significant difference between the VNB+Letrozole arms compared to the VNB or Letrozole monotherapy arms.

* Incidence and severity of Adverse Events (assessed by CTCAE v.4.03)
* Incidence of treatment interruptions due to toxicity

Pierre Fabre Laboratories

SOLTI Breast Cancer Research Group

Supervised Exercise Group: Customized and supervised exercise high intensity training program during 2-3 weeks previous surgery.

Supervised Stretching Group: a stretching and body balance classes will be developed to control the possible confounders and to control the exercise level of participants.

Exercise intervention adapted to maximum rate of oxygen consumption measured during incremental exercise (VO2level) of each patient, working between 60% to 100% VO2level. The activity will be walk-run in a treadmill. 10 sessions minimum

Exercise

Stretching and relaxing exercise during 30 minutes. Same number of sessions as intervention group

Stretching

Study Director

Observational study to evaluate the effect of physical exercise prior to surgery and adjuvant systemic treatment in women with newly diagnosed operable hormone receptor(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers

Effect of exercise on tumor aggressiveness and the impact on patients' quality of life.

Exercise is a safe and effective treatment for women diagnosed with breast cancer (BC), that has an integral benefit during and after treatments, however, the effect at the tumour microenvironment it is unknown; previous studies have evaluated the association between exercise and BC, finding a positive influence on it, which suggest that exercise could reduce the aggressiveness of the tumour. This study will explore the exercise impact in tumor microenvironment, as part of the therapy given to the patients prior to surgery and treatment. In addition, different serum biomarkers involved and the tailoring of exercise for these women will be evaluated. The effect of exercise on treatments secondary effects, biomarkers and quality of life will be evaluated after 6 months of BC surgery. This project will open a window of opportunity to explore new translational research as well as new treatment vias to the patients of this breast cancer subgroup.

Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients

Effect of Physical Exercise on Ki-67 Levels in Women With Operable Breast Cancer Hormonal Receptor Positive, HER2 Negative

Tumor proliferation (Ki67) will be assessed immunohistochemically at basal biopsies versus post-surgery tumor samples.

A 50-gene quantitative polymerase chain reaction (qPCR) assay (PAM50) will be used to identify the intrinsic biological subtypes using RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tissue from baseline biopsies samples and post-surgery tumor samples.

A 50-gene qPCR assay (PAM50) will be used to identify the intrinsic biological subtypes using RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tissue from baseline biopsies samples and post-surgery tumor samples.

VEGF will be evaluated on tissue from baseline biopsies samples and post-surgery tumor samples by Immunohistochemistry (IHC)

HIF-1 will be evaluated on tissue from baseline biopsies samples and post-surgery tumor samples by Immunohistochemistry (IHC)

Levels of cleaved caspase 3 will be evaluated on tissue from baseline biopsies samples and post-surgery tumor samples by Immunohistochemistry (IHC)

VO2peak will be obtained of the Cardiopulmonary exercise testing (CPET) performed at baseline and after the exercise program until surgery.

Change in body composition will be assessed by bioimpedance parameters. Bioelectrical impedance analysis (BIA) is a commonly used method for estimating body composition, and in particular body fat, and will be performed at baseline and after the exercise program until surgery.

Change in fatigue levels will be assessed by questionnaire Functional Assessment of Cancer Therapy: Fatigue (FACT-F). The physical well-being domain has 7 items with scores from 0 to 28 points; social/family well-being, 7 items with score from 0 to 28 points; emotional well-being, 6 items with score from 0 to 24 points; functional well-being, 7 items with score from 0 to 28 points; and fatigue subscale, 13 items with score from 0 to 52. Each item has ﬁve likert-type options graduated from 0 to 4: "Not at all", "A little bit"; Somewhat"; "Quite a bit"; "Very much'. The ﬁnal score of FACT-F is obtained by adding the scores of the ﬁve domains, and may vary from 0 to 160 points. The higher the number of points, the better the quality of life and the less the fatigue of the patients is. To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.

Change in quality of life levels will be assessed by questionnaire Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B). The FACT-B is a breast cancer-specific HRQoL instrument of the FACIT system. The 37-item are divided into five subscales, namely physical (PWB), social/family (SWB), emotional (EWB), functional well-beings (FWB), and the additional concerns for breast cancer (BCS). Each item is rated on a 5-point Likert scale. Negatively worded items were recoded such that a higher score indicates a better HRQoL. The FACT-B total score is the sum of scores of all five subscales.

Change in depression levels will be assessed by questionnaire Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item measure assessing symptoms of depression with items phrased as self-statements (e.g., "I felt hopeful about the future"). Respondents rate how frequently each item applied to them over the course of the past week. Ratings were based on a 4-point Likert scale ranging from 0 (rarely or none of the time \[less than 1 day\]) to 3 (most or all of the time \[5-7 days\]).

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Faculty of Physical Activity and Sport Sciences (INEF)

Spanish Breast Cancer Research Group

Triple Negative Breast Neoplasms

Epirubicin

Immunomodulating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will received paclitaxel 80 mg/m2 IV weekly from week 1 to 12 and then an association of epirubicin 90 mg/m2 IV and cyclophosphamide 600 mg/m2 IV Q 2 weeks from week 14 to 20.

Durvalumab will be administered at 1500 mg IV at week 14 and week 18.

Patients will received paclitaxel 80 mg/m2 IV weekly from week 1 to 12 and then an association of epirubicin 90 mg/m2 IV and cyclophosphamide 600 mg/m2 IV Q 2 weeks from week 14 to 20.

90 mg/m2 IV Q 2 weeks from week 14 to week 20

600 mg/m2 IV Q 2 weeks from week 14 to week 20

Javier Carrasco, MD, PhD

Jean-Luc Canon, MD

François Duhoux, MD, PhD

The study has a phase Ib and a phase II part.

* The phase Ib aims to evaluate the safety and tolerability of durvalumab in combination with a dose- dense EC regimen in a neoadjuvant setting for early breast cancer.
* The phase II aims to explore the efficacy of durvalumab in combination with a dose-dense EC regimen in a neoadjuvant setting for early breast cancer.

Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(-) and Triple Negative Breast Cancer.

A Phase IB/II Study of Durvalumab (MEDI4736) Combined With Dose-dense EC in a Neoadjuvant Setting for Patients With Locally Advanced Luminal B HER2(-) or Triple Negative Breast Cancers.

Rate of complete pathological responses will be evaluated as a surrogate endpoint to evaluate efficacy

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Grand Hôpital de Charleroi

Pharmaceutical Solutions

1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.

Eribulin

Javier Cortés, MD

Aleix Prat, MD

This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with operable Stage III HER2 non-overexpressing breast cancer.

Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer

A Phase II, Open-label, Single-arm, Exploratory Pharmacogenomic Study of Single Agent Eribulin (HALAVEN®) as Neoadjuvant Treatment for Operable Stage I-II HER2 Non-overexpressing Breast Cancer.

pCRB , defined as the complete absence of invasive carcinoma in the breast on histological examination at the time of definitive surgery, according to the NSABP guidelines

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER	NCT03712956	Breast Cancer	Caelyx®	18 Years - 70 Years	European Institute of Oncology
Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases	NCT03970967	Breast Carcinom... Metastatic Brea... Invasive Breast... Distant Metasta...	Device: Radiati...	45 Years -	Alpha Tau Medical LTD.
Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer:	NCT03875573	Luminal B	Durvalumab Stereotactic Bo... Oleclumab	18 Years -	Jules Bordet Institute
Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)	NCT01779479	Primary Breast ...	Cabacitaxel Paclitaxel	18 Years -	German Breast Group
Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)	NCT02802748	Breast Cancer	Oral Vinorelbin... Letrozole	18 Years -	SOLTI Breast Cancer Research Group
Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients	NCT03860740	Breast Cancer Luminal B	Exercise Stretching	18 Years -	Spanish Breast Cancer Research Group
Alpha Radiation Emitters Device for the Treatment of Newly Diagnosed Breast Carcinoma Patients With Distant Metastases	NCT03970967	Breast Carcinom... Metastatic Brea... Invasive Breast... Distant Metasta...	Device: Radiati...	45 Years -	Alpha Tau Medical LTD.
Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients	NCT03860740	Breast Cancer Luminal B	Exercise Stretching	18 Years -	Spanish Breast Cancer Research Group
Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(-) and Triple Negative Breast Cancer.	NCT03356860	Breast Cancer Triple Negative... Luminal B	Paclitaxel Epirubicin Cyclophosphamid... Durvalumab	18 Years -	Grand Hôpital de Charleroi
Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer	NCT01669252	Breast Cancer	Eribulin	18 Years -	SOLTI Breast Cancer Research Group

Spots Global Cancer Trial Database for luminal b

Every month we try and update this database with for luminal b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for luminal b

Every month we try and update this database with for luminal b cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for luminal b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.