Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Epirubicin

Lenograstim

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Adjuvants, Immunologic

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

2 cycles of chemotherapy with administration of G-CSF (filgrastim or lenograstim) on D2, D4 to D7 or D8..

Realization of blood sampling at D1, D4, D8 and D14

2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2.

Realization of blood sampling at D1, D4, D8 and D14

- Arm 1: 2 cycles of chemotherapy with administration of G-CSF (filgrastim or lenograstim) on D2, D4 to D7 or D8..

Realization of blood sampling at D1, D4, D8 and D14

Dense dose epirubicin-cyclophosphamide chemotherapy and G-CSF (filgrastim, lenograstim)

- Arm 2: 2 cycles of chemotherapy with administration of peg-G-CSF (pegfilgrastim) on D2.

Realization of blood sampling at D1, D4, D8 and D14

Dense dose epirubicin-cyclophosphamide chemotherapy with administration of peg-G-CSF (pegfilgrastim)

LADOIRE SL SYLVAIN, coordinator

SCHMITT AS ANTONIN, methodoordinator

LADOIRE SL SYLVAIN, principal investigator

Sophie Parnalland

Patients including of localized breast cancer will require chemotherapy treatment with epirubicin - cyclophosphamide (EC) followed by treatment with docetaxel or paclitaxel. In addition to this chemotherapy, the investigator will prescribe injections of granulocyte growth factors (G-CSF), to stimulate the growth of white blood cells. Patients will be randomized to either a peg-G-CSF arm or a G-CSF arm, prescribed at different times.

The aim is to determine whether one of the two treatment regimens best limits the risk of a decrease in white blood cells

For this tudy : patients will be randomized to either :

* with administration of peg-G-CSF (administration on D2)
* with administration of G-CSF (administration on D4 to D7 or D8)

This study aims to model the effect of exogenous G-CSF for the evolution of polymorphonuclear neutrophils as a function of time and to explain the pharmacodynamic variability during the administration of chemotherapy such as EC-dense dose administered as an adjuvant or neo-adjuvant in patients treated for localized breast cancer.

Patients will be randomized :

* Either to a peg-G-CSF arm (with administration of peg-G-CSF on D2)
* Either to a G-CSF arm (with administration from D4 to D7 or D8). Blood samplig will be taken at D1, D4, D8 and D14 for each arm.

Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration

Variation of Neutrophils concentration will be assess by blood count formula performed during the 2 first cycle of Epirubicin-cyclophosphamide treatment.

Centre Georges Francois Leclerc

Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM

20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer

Per-Operative Radiotherapy technique by Papillon +TM

Frédérique JACQUINOT

Annie ITIE

Vivien FUNG, Dr

Damien CHAUVIERE

Marie-Eve FOUCHE-CHAND, Dr

Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.

Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer

Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study

pourcentage of patient with toxicities of grade 3 and more (by CTCAE v5.0) related to per-operative radiotherapy and that occured until 6 months after performing

global safety (assessed by CTCAE V5.0) of per-operative radiotherapy

To evaluate local disease free survival at 5 years of per-operative radiotherapy

To evaluate disease free survival at 5 years of per-operative radiotherapy

QLQ-C30 and QLQ BR-23 EORTC questionnaires

Centre Antoine Lacassagne

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Obesity

Women randomized to the "connected device" arm will follow a 6-month exercise program using a connected device that includes an activity tracker and subscription to an exercise and physical activity management program through a smartphone application and a website. They will also receive international recommendations on physical activity.

Women randomized to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education. They will also receive international recommendations on physical activity.

Women will benefit from both the "connected device" intervention and the "therapeutic education" intervention and receive international recommendations on physical activity.

Women will receive standard care, i.e., international recommendations on physical activity, without further intervention.

Women will receive a connected wristband (https://www.carefitness.com/) and a subscription to a smartphone application and website (http://disco.biomouv.com/). They will have to participate in a 6-month personalized non-supervised exercise program consisting of 3 weekly sessions of 20 min to 1-hr of moderate-to-vigorous physical activity (≥3 METs): 2 sessions of brisk walking and 1 session of muscle strengthening. Women should wear the wristband daily to track their number of steps (automatic Bluetooth synchronization to the application). Duration and intensity of sessions and target number of daily steps will progressively increase (+15% up to 10,000 steps) to place the patients in a progression dynamic. Women will receive phone-based follow-up at 1 week, 2 months, and 4 months.

Connected device

Women will be invited to participate in the 6-month therapeutic patient education program "Mieux manger, mieux bouger" ("Eat better, move better") elaborated at the Léon Bérard cancer center. The program consists in four sessions:

* a 1-hour individual session of "educational diagnosis" to assess their needs and establish a contract of objectives,
* two "educational sessions" of 1h30 each using tools, in group of 10 patients maximum to improve their daily practice of physical activity,
* a 1-hour individual session of "educational assessment" to evaluate whether their objectives were reached.

Therapeutic education

Béatrice Fervers, MD, PhD

The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

Rationale:

In women with breast cancer, weight gain, obesity, and lack of physical activity have been shown to increase the risk of comorbidities and deleterious long-term outcomes. Despite the safety of physical activity and the benefits of physical activity performed concomitant to treatment on fatigue, quality of life, and possibly survival, its implementation is not systematic in the cancer care pathway.

Methods:

The DISCO study is a randomized, controlled, multicenter intervention study that will be conducted among 432 women treated for localized breast cancer. Patients will be randomly assigned to one of the four arms of the study according to a 1:1:1:1 ratio.

* Women allocated to the "connected device" arm will benefit from a 6-month personalized exercise program consisting of three weekly sessions of aerobic and strength exercises, carried out autonomously with a connected device (wristband, smartphone application, website).
* Women allocated to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education.
* Women allocated to the "combined" arm will benefit from both interventions in parallel.
* Women allocated to the "control" arm will receive standard care, i.e., international recommendations on physical activity.

Evaluations will be conducted at inclusion (T1, baseline), 6 months (T2, end of interventions), and 12 months (T3, 12 months post-inclusion to study maintenance of behavior change) on the following parameters: level of physical activity and sedentary behavior (RPAQ self-administered questionnaire), physical condition assessed by functional tests (6-min walking test, sit-to-stand test, hang-grip test, sit-and-reach flexibility test, single-leg balance test), anthropometrics (weight, height, waist circumference, hip circumference, calculated body mass index), body composition (fat mass, lean body mass, fat free mass, water), biological factors (blood sample at baseline and 6 months), lifestyle factors (tobacco status, alcohol intake), psychological factors (quality of life assessed by the EORTC QLQ-C30 / BR-23 questionnaire, health-related quality of life assessed by the EQ-5D-5L questionnaire, fatigue assessed by the PFS-12 questionnaire), socio-economic parameters (social deprivation assessed by the EPICES questionnaire, level of education, family situation, professional status assessed through a self-administered questionnaire). Clinical data will be obtained from patients' medical records. Acceptability of connected device and of therapeutic education program will be assessed within the population. The medico-economic impact of the interventions will be evaluated through cost-utility and cost-effectiveness analyses. Data will be recorded using an e-CRF. Women will be recruited over 2 years and will be followed up for 12 months.

Hypothesis:

The research hypothesis is that patients participating in the 6-month intervention with the connected device or in the 6-month therapeutic education program will be more likely to achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

Expected results are to identify best modalities to implement exercise during and after breast cancer treatment. In a public health perspective, the challenge is to reduce geographical, social, and organizational inequalities among patients to practice regular physical activity and to promote the systematic integration of physical activity in routine cancer care.

Two interventions, each alone and in combination, are evaluated in parallel against a control group. Women assigned to the "connected device" arm will follow a 6-month exercise program using a connected device. Women assigned to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education in physical activity. Women assigned to the "combined" arm will follow both programs. Women assigned to the "control" arm will receive international recommendations on physical activity.

Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer

Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer

The cost-utility of implementing each intervention will be assessed.

The cost-effectiveness of implementing each intervention will be assessed.

Assessed by the RPAQ self-administered questionnaire

Time spent in different intensities of physical activity, time spent in sedentary activities

weight in kilograms and height in meters will be combined to report BMI in kg/m\^2

fat mass measured using bioelectronic impedancemetry

lean body mass measured using bioelectronic impedancemetry

fat free mass measured using bioelectronic impedancemetry

water measured using bioelectronic impedancemetry

EORTC QLQ-C30 questionnaire and its BR-23 module

Change in professional status, return to work, and perceived difficulty at work by a self-administered questionnaire.

Self-administered qualitative questionnaire used in social psychology science

self-administered qualitative questionnaire used in social psychology science

Refusal rate among eligible patients to whom the study was presented

Fondation ARC

National Cancer Institute, France

Fondation pour la Recherche Médicale

Cancéropôle Lyon Auvergne Rhône-Alpes

AG2R La Mondiale

Centre Leon Berard

Death

Blood samples will be collected on the first day of the first cycle of chemotherapy (before injection of chemotherapy), on the first day of the third cycle (before injection of chemotherapy), on day of surgery and 6 months after surgery and in case of relapse.

Tumor samples will be collected on diagnosis, on surgery and on the first day of the third chemotherapy course (optional).

Blood and tumor sample

Olivier TREDAN, MD

This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer.

40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.

Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation.

Blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.

Tumor sample will be collected on diagnosis as much as possible and on surgery.

Patients will be followed during 5 years.

Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer

Rate of histopathologic response (IHC). Analysis of lymphocyte subpopulations (whole blood - flow cytometry). Analysis of the frequency of immune cells, the phenotype and functional status on the site of the tumor (fixed tissue - IHC). Analysis of the functional status of sub-populations of DC and lymphocytes of innate immunity (fresh whole blood - flow cytometry). Analysis of BCR and TCR repertoires (mononuclear cells - PCR). Identification of TAA expressed by the tumor (plasma, tumor - ELISA, IHC).Analysis of the humoral response against TAA (plasma - ELISA).

Analysis in plasma of the rate of apoptotic tumor cells, of TAA (CEA and MUC1 ELISA), of tumor DNA and endogenous ligands of TLR (HMGB1 ELISA) Assay of cytokines and chemokines in plasma Analysis of the expression of proteins involved in the translocation of CRT to the cell surface (fixed-frozen tissue - IHC or immunoblotting) Analysis on the tumor (IHC or immunoblotting) of degradation of BAP31, activation of caspase 8/Bax/Bak, phosphorylation of eIF2 and exposure of surface CRT, KDEL receptor and ERp57

Analysis of P2X7 and TLR4 polymorphisms on circulating cells (plasma)

Menopause

Hormones

Estrogens

Mitogens

Anastrozole

Aromatase Inhibitors

Antineoplastic Agents, Hormonal

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

ARV-471 taken once daily until surgical resection

Anastrozole 1mg taken once daily until surgical resection

ARV-471

Participants will have surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)

Surgical resection of breast tumor

This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with ER+/HER2- localized breast cancer.

This is a Phase 2, open-label, randomized, non-comparative proof of concept study of ARV-471 or anastrozole in participants with ER+/HER2- breast cancer amenable to definitive surgical resection. The main goal of this study is to evaluate the biological activity of ARV-471 and anastrozole, respectively.

A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery

An Open-label, Randomized, Non-comparative Phase 2 Study of ARV-471 or Anastrozole in Post-menopausal Women With ER+/HER2- Breast Cancer in the Neoadjuvant Setting

Percent change in Ki-67 expression between baseline and C1D15 tumor biopsies

Incidence of all adverse events, serious adverse events, and adverse events leading to study drug discontinuation

Pathologic stage at the time of surgical resection

pathologic complete response rate at the time of surgical resection

modified Pre-operative Endocrine Prognostic Index score at the time of surgical resection

radiographical response rate in the primary tumor during cycle 6

Best percentage change from baseline up to C6D1 in caliper measurement of the primary tumor

Pfizer

Arvinas Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Fatigue

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Oral organic Germaium tablets on the tongue 3 to 5 times per day as tolerated

Organic Germanium

Placebo tablets orally 3 - 5 times per day as tolerated

Placebo

Terry Thomas, MS, CCRC

Emily Grade, MD

Participants will be diagnosed with localized prostate or breast cancer and be scheduled to undergo external beam radiation therapy. Participants will either receive a placebo or organic germanium to be taken 5 times a day starting the day of their first radiation and continuing through the 1 month follow-up visit. Weekly Quality of life forms will be completed through the one month follow up visit and then at the 3 month follow up visit. Labs will be done prior to the start of treatment, at the end of treatment and at the one and three month follow-up visits.

With the increasing public use of complementary medicines, most researchers agree that there is a compelling need to study the safety and efficacy of these agents in humans by means of appropriately designed double-blind, placebo controlled clinical trials. With fatigue affecting 96% of the cancer patient population and little more than life style alterations offered as an intervention, the need to evaluate putative and innovative approaches for fatigue is a high priority. The NIH released a "State of the Science" statement in 2002 which concluded that fatigue is a serious cause of morbidity, being the most prevalent symptom experienced by cancer patients. This expert panel also concluded that the major barrier to effective management of fatigue includes a lack of awareness of this fact, the lack of knowledge of the causes of fatigue, and the lack of proven methods to treat fatigue. Presently, clinical trials evaluating intervention for cancer fatigue are lacking.

Organic germanium literature states that it may be an effective agent for combating fatigue with virtually no toxicities. Since virtually all cancer patients receiving radiation therapy experience fatigue, the use of this drug should be evaluated as an intervention for non-anemic fatigue in breast and prostate cancer patients undergoing a definitive course of radiation therapy. We intend to test whether organic germanium is able to reduce the fatigue experienced by patients undergoing radiation therapy and if this reduction in fatigue correlates to an improvement in quality of life for these patients. Changes in the patients' mood will also be evaluated. We will also collect information on the toxicity profile of Organic germanium and try to determine when the peak fatigue time occurs and possibly when they recover. This information will be utilized to see if a larger study is warranted.

2.0 OBJECTIVES 2.1 Primary: To determine if Organic germanium is effective in decreasing severity of fatigue in patients undergoing definitive radiation therapy for prostate or breast cancer at the one month follow-up visit.

2.2 Secondary 2.2.1 To compare changes in patients' moods between Organic germanium versus placebo at the one month follow-up visit 2.2.2 To compare the duration of fatigue between organic germanium and placebo 2.2.3 To further evaluate the toxicity profile of organic germanium using the CTCAE version 3 scale.

2.2.4 To determine the Peak time of fatigue in patients receiving external beam radiotherapy or high dose rate brachytherapy for breast or prostate cancer.

2.2.5 To determine the tolerability of 5 tablets per day as the dosing schema. 2.2.6 To determine when the patients recover from their radiation induced fatigue

Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue

A Phase II, Pilot, Randomized, Double-blind Study Comparing the Effectiveness Organic Germanium to Placebo in Decreasing the Severity of Fatigue in Patients Undergoing Radiation Therapy for Prostae and Bbreast Cancers

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration	NCT05296317	Localized Breas...	Dense dose epir... Dense dose epir...	18 Years -	Centre Georges Francois Leclerc
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer	NCT04680715	Localized Breas...	Per-Operative R...	65 Years -	Centre Antoine Lacassagne
Per-Operative Radiotherapy by Papillon +TM in Localized Breast Cancer	NCT04680715	Localized Breas...	Per-Operative R...	65 Years -	Centre Antoine Lacassagne
Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer	NCT03529383	Breast Cancer	Connected devic... Therapeutic edu...	18 Years - 75 Years	Centre Leon Berard
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer	NCT01440413	Breast Cancer	Blood and tumor...	18 Years -	Centre Leon Berard
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer	NCT01440413	Breast Cancer	Blood and tumor...	18 Years -	Centre Leon Berard
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery	NCT05549505	Breast Cancer	ARV-471 Anastrozole Surgical resect...	18 Years -	Arvinas Inc.
Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue	NCT00651417	Localized Breas... Localized Prost... Patients Receiv...	Organic Germani... Placebo	18 Years -	Arizona Oncology Services

Spots Global Cancer Trial Database for localized breast cancer