Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Each patient will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:

* Screening
* Pre-surgery treatment
* Surgery and study device implant
* Post-surgery follow-up

REGENERA breast implant implantation

Margherita Tamplenizza

Mario Rietjens

Manuela Roncella

Benigno Acea Nebril

The goals of this clinical trial are:

* demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
* demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.

Participants will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:

* Screening
* Pre-surgery treatment
* Surgery and study device implant
* Post-surgery follow-up up to 5 years

Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy

A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy

The rate of AEs with a causal relationship to REGENERA should be \<5% at 3 months after implant.

At least 7 in a 0-10 Visual Analogue Scale, VAS.

At least 40 in an "ad hoc" questionnaire (12-60 scale).

An imaging evaluation questionnaire will be provided for investigators to fill out.

The rate of REGENERA-related SAEs should be \<5% at each follow-up after 3 months and up to 18 months.

The rate of REGENERA-related SAEs should be \<7% at each follow-up after 18 months and up to 5 years.

Tensive SRL

Advanced breast cancer patients with positive MUC1 expression are the indications of this clinical study. Current conventional treatments are ineffective for these patients or there is no effective treatment plan available for them. No control group is established and a single arm design is used.

This clinical study is the first application of AJMUC1 in the clinical treatment of MUC1-positive advanced breast cancer patients. The main purpose is to assess the safety and feasibility of the product in clinical use. Therefore, according to the principle of "3+3" dose escalation design, this study explored the maximum tolerated dose of AJMUC1 for the treatment of MUC1-positive advanced breast cancer.

At the same time, the efficacy of AJMUC1 in the treatment of MUC1-positive advanced breast cancer will be observed and factors that could affect the safety and efficacy of the therapy will be exploringly evaluated.

AJMUC1 is a genetically modified T cell therapeutic product targeting the aberrantly glycosylated MUC1 protein. CAR targeting MUC1 is introduced into autologous T cells by lentiviral vector, so that T cells expressing the receptor can recognize and kill MUC1 positive tumor cells. Preclinical studies have shown that binding of scFv targeting MUC1 to the MUC1 epitope on the surface of the target cell can induce the costimulatory CD28 and CD3ζ costimulatory domains to activate downstream signaling pathways and promote T cell activation and expansion. Activated CAR-T cells secrete a series of inflammatory cytokines and chemokines, leading to apoptosis and necrosis of target tumor cells. Following introduction of a CAR structure, the PD-1 gene of CAR-T cells is knocked out using CRISPR/Cas9, so that the CAR-T cell does not express PD-1, resulting in improved tumor killing efficiency of AJMUC due to the release of inhibition in the signaling pathway PD-1/PD-L1 in the tumor microenvironment.

AJMUC1- PD-1 gene knockout anti-MUC1 CAR-T cells

Erwei Song, MD, PhD

This exploratory clinical study aims to assess the safety and preliminary efficacy of an immunotherapy using PD-1 knockout anti-MUC1 CAR-T cells in the treatment of advanced MUC1-positive breast cancer

This is a single-center, open-label, dose-escalation exploratory study investigating the safety,tolerability and preliminary efficacy of AJMUC1, PD-1 knockout CAR-T cells targeting aberrantly glycosylated MUC1, in the treatment of patients with advanced MUC1 positive breast cancer. The primary objective of this study is to evaluate the safety, tolerability, biological activity, and preliminary antitumor efficacy of AJMUC1. The study adopts a "3+3" dose escalation design to identify the maximum tolerated dose (MTD)/ maximum administered dose (MAD). Three doses are set: 3×105 CAR T cells/kg, 1×106 CAR T cells/kg and 3×106 CAR T cells/kg, with a total of 15 patients planned by the data cutoff date. Participants may receive one, two, three or more cycles of AJMUC1 infusion dependent on the adverse effects and potential clinical benefits.. This study is initiated by the investigators and approved by the Human Ethics Committee of Sun Yat-sen Memorial Hospital affiliated with Sun Yat-sen University. All patients have signed informed consent.

PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer

Exploratory Clinical Study of PD-1 Knockout Targeting MUC1 CAR-T Cells (AJMUC1) in the Treatment of MUC1-positive Advanced Breast Cancer

The serum cytokine included IL-1β, IL-2R, IL-6, IL-8, TNF and IL-10

Guangzhou Anjie Biomedical Technology Co., Ltd.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Sirolimus

Gedatolisib

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Gedatolisib is a potent, reversible dual inhibitor that selectively targets phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in biochemical and cellular assays.

Nadene Zack, MS

Erica Stringer-Reasor, MD

Anne F Schott, MD

Robert Weslowski, MD

Rachel Layman, MD

Jennifer Specht, MD

Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)

Celcuity Inc

Triple Negative Breast Neoplasms

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Olaparib

Adenosine

Poly(ADP-ribose) Polymerase Inhibitors

Neurotransmitter Agents

One week of Olaparib alone followed by 5 weeks of Olaparib and concurrent loco-regional radiotherapy. Five levels of dose of Olaparib are expected.

five levels of dose, per os administration, twice daily each day

3D conformal radiotherapy or intensity-modulated radiotherapy (IMRT), Simultaneous Integrated Boost (SIB), postoperative radiotherapy

Radiation therapy

Youlia KIROVA, MD

A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease.

Open label phase I, dose escalation trial for patients with triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated with residual disease (after neoadjuvant chemotherapy).

Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

A Phase I of Olaparib With Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (Triple Negative Breast Cancer) or Patient With Operated TNBC With Residual Disease

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Incidence of early Dose Limited Toxicity (DLTs: early adverse effects related to Olaparib administered with concurrent radiotherapy) to determinate the Maximal Tolerated Dose (MTD) of Olaparib administered with concurrent loco regional radiotherapy in patients who have triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated patient with residual disease (after neoadjuvant chemotherapy).

Incidence of Serious Adverse Events (SAEs), graded according to NCI-CTCAE version 4.03 criteria

Incidence and severity of Adverse Events (AEs), graded according to NCI-CTCAE version 4.03 criteria

Incidence and severity of laboratory abnormalities, graded according to NCI-CTCAE version 4.03 criteria

Incidence of acute toxicity 2 weeks and 6 weeks after the end of radiotherapy

Incidence of late toxicity at 1 year and at 2 years as of initiation of radiation therapy

Incidence of treatment discontinuations and treatment modifications due to AEs

Evaluation of the Objective Response Rate (ORR) to treatment

Evaluation of the Complete Response Rate to treatment

Evaluation of Pathological Response Rate (pRR) after salvage surgery

Evaluation of the loco-regional Progression Free Survival (l-PFS)

Evaluation of the Progression Free Survival (PFS) or Disease Free survival (DFS)

Evaluation of the disease specific survival rate.

Exploration of biomarkers of Olaparib associated with radiotherapy on biopsies.

AstraZeneca

Institut Curie

Newly diagnosed bone only oligometastatic breast cancers with 1-3 bone metastases will be enrolled in this protocol. Patients will receive SBRT to all metastatic sites.

This is a prospective study of breast bone only oligometastases (up to three sites). Following systemic treatment and primary tumor control, patients will receive SBRT to all metastatic sites. Data on toxicities and oncological outcomes will be collected for future analysis. There will be no change in the standard systemic therapy nor the local therapy of the primary tumor.

Stereotactic Body Radiotherapy

Abdulmajeed H Dayyat, MD

Farah Zahran

Abdulmajeed Dayyat, MD

This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.

SBRT for Breast Cancer Oligometastases

Stereotactic Body Radiotherapy for Bone Only Oligometastatic Breast Cancer: A Prospective Study

the interval from diagnosis until disease progression

time from diagnosis to death from any cause or last follow-up

the interval from diagnosis until local progression of the treated metastases

the interval from diagnosis until appearance of new metastases

CTCAE v5. for acute and chronic toxicity reporting and scoring

King Hussein Cancer Center

Consultant Radiation Oncologist

Capecitabine

Antimetabolites

Phenotyping DPD with enzyme activity measure and uracil dosage

DPD activity assessment

Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of

Christine LOVERA

Jérôme Barriere

Remy Largilier

Ophélie CASSUTO

Anne CREISSON

Georges Garnier

This study evaluates the Impact of DihydroPyrimidine Dehydrogenase (DPD) activity on the efficacy of Capecitabine in patients with metastatic breast cancer. The DPD phenotype before the initiation of treatment will be assess and then the patient will be follow up during the treatment with Capecitabine up to 24 month.

This is an open-label multi-center prospective cohort study to compare the response of patients with high phenotype to patients with normal phenotype. The analyzes performed will focus on clinical and biological criteria.

Study of the Impact of DPD Activity on the Efficacy of Capecitabine

The primary endpoint will be the 6-month objective response to treatment measured using the RECIST 1.1 scale, or PERCIST 1.0. The objective response is defined as the aggregation of the complete + partial response against stabilization + progression.

The distribution of the objective response rate with respect to the value of individual lymphocyte DPD activity before treatment will be examined. This analysis will consist in comparing the objective response rate between patients with a proficient DPD phenotype, measured by lymphocyte DPD activity (\> at the 3rd quartile, ie 25% of the initial population) and non-deficient patients with DPD (including phenotype). between the 13th and 75th percentiles of the initial population).

Cerbaliance

Centre Antoine Lacassagne

Letrozole

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the French participating centres.

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and wish to preserve their fertility by undergoing oocyte/embryo cryopreservation at the Belgian participating centres.

this cohort includes all newly diagnosed breast cancer patients who are candidates to receive (neo)adjuvant chemotherapy and who have access to the Fertility Clinics in all the participating centres but are not willing to preserve their fertility by undergoing oocyte/embryo cryopreservation.

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.

"Standard Protocol": letrozole is orally administered (5mg/d) from cycle day 2-3 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering.

"Random start" protocol: letrozole is administered throughout the stimulation together with gonadotropins.

GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.

Oocytes are collected 36h after ovulation triggering with GnRH agonist.

Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or "random start"). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.

"Standard Protocol": Gonadotrophins started from cycle day 2-3 throughout the ovarian stimulation until ovulation triggering.

"Random start" protocol: Gonadotrophins started at any time of the cycle and throughout the stimulation.

GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.

Oocytes are collected 36h after ovulation triggering with GnRH agonist.

standard-stimulated cohort

Isabelle Demeestere, MD,PhD

Julie Dechene

Julie Dechène

Lydia Ait Ahcene

Oranite Goldrat, Md, PhD

Romain Imbert, MD

Chantal Schugens

Carine Garnier

Annick Delvigne, MD, PhD

Aline BARBERIO

audrey Mailliez, MD

Christine Decanter, MD

Matteo Lambertini, MD, PhD

Isabelle Demeestere, MD, PhD

This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.

Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a Gonadotropin Releasing Hormone-GnRH agonist.

After retrieval, oocytes are denuded and matured oocytes are subjected to fertilization before embryo freezing or direct vitrification.

Primary objective is to evaluate the efficacy of performing a controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy in terms of mature oocytes collected.

3 groups:

* 113 patients in the standard-stimulated cohort,
* 113 patients in the letrozole-stimulated cohort,
* 339 patients in the non-stimulated cohort.

Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

A Multicenter Prospective coHort Study of Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)

Adverse events reporting during COS (Ovarian Hyperstimulation syndrome-OHSS)

Total gonadotropin doses (International Unit- IU)

type of stimulation (standard or random-start).

Maturation rate (number of total oocyte collected/number of mature oocytes)

Number of pregnancies and outcomes (premature delivery, miscarriage, abortion, delivery healthy babies, congenital malformation).

Anti-Mullerian Hormone (AMH) measurements AMH ng/ml

Follicle-Stimulating Hormone (FSH) measurements FSH IU/L

Amenorrhea rate (6months without spontaneous menstruation)

Fertilization rate (number of oocyte fertilized/number of embryo obtained)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy	NCT05941299	Mastectomy, Seg... Breast Neoplasm...	REGENERA breast...	40 Years - 70 Years	Tensive SRL
PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer	NCT05812326	Advanced Breast... Breast Neoplasm...	AJMUC1- PD-1 ge...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer	NCT05812326	Advanced Breast... Breast Neoplasm...	AJMUC1- PD-1 ge...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009	NCT05134922	Breast Neoplasm...	Gedatolisib	18 Years -	Celcuity Inc
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)	NCT03109080	Breast Neoplasm... Breast Neoplasm... Radiotherapy Si...	Olaparib Radiation thera...	18 Years -	Institut Curie
SBRT for Breast Cancer Oligometastases	NCT04424732	Breast Neoplasm...	Stereotactic Bo...	18 Years -	King Hussein Cancer Center
Study of the Impact of DPD Activity on the Efficacy of Capecitabine	NCT04198727	Breast Neoplasm...	DPD activity as... Capecitabine	18 Years -	Centre Antoine Lacassagne
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009	NCT05134922	Breast Neoplasm...	Gedatolisib	18 Years -	Celcuity Inc
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)	NCT03109080	Breast Neoplasm... Breast Neoplasm... Radiotherapy Si...	Olaparib Radiation thera...	18 Years -	Institut Curie
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)	NCT03109080	Breast Neoplasm... Breast Neoplasm... Radiotherapy Si...	Olaparib Radiation thera...	18 Years -	Institut Curie
Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE)	NCT04289805	Breast Neoplasm...	Letrozole standard-stimul...	18 Years - 40 Years	Erasme University Hospital

Spots Global Cancer Trial Database for breast neoplasm malignant female