Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

tamoxifen

The biological response to treatment with tamoxifen in the preoperative situation is studying in this protocol. This study will enrolls patients with non-metastatic breast cancer HR +.

The relationship between the CYP2D6 polymorphism, pharmacokinetics and biological efficacy of TAM will be studied.

Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+

Phase II Study Evaluating According to the Polymorphism of CYP2D6, the Rate of Biological Response to Treatment With Tamoxifen (TAM) Administered in Pre-operative Situation in Patients With Breast Cancer Non Metastatic HR+

The primary endpoint is the determination of the variation in the KI-67 expression, a marker of cell proliferation, at the tumour level between the initial biopsy (T0) and after 5 weeks of tamoxifen treatment, in relation to cytochrome 2D6 polymorphisms. A 50% geometric reduction in KI-67 expression at 5 to 7 weeks should be considered as a major response

Institut Cancerologie de l'Ouest

Behaviors and Mental Disorders

Quality of Life

35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons.

35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons.

standard conservative surgery with no use of any plastic techniques

Standard quadrantectomy

Integration of plastic techniques with oncological procedures

oncoplastic breast surgery

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.

This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype and patient satisfaction.

The Impact of Oncoplastic Breast Surgery on the Oncological Safety and Patient Satisfaction

Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life

Ain Shams University

Lecturer of general surgery

Symptoms and General Pathology

Nausea

Vomiting

Signs and Symptoms, Digestive

Antirheumatic Agents

Sinomenine

12 tablets in 3 days at each of the CT courses: 2 on the day before evening of the CT courses; 2 on the morning, noon and evening of the CT courses; 2 on morning and noon of the day after the CT courses.

Cocculine®

placebo

RAY-COQUARD Isabelle, MD

The purpose of the study is to determine whether a homeopathic remedy (Cocculine®) is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer.

Eligible patients will be randomly assigned to one of 2-arms: Cocculine® or placebo.

The number of patients required to demonstrate a 0.5-point reduction in nausea on a visual analogue scale, assuming an alpha risk of 5% in a two-sided test and 85% power, is 396 (198 per arm). It has been estimated that the enrollment period should be 18 months.

The proportion of women with breast cancer treated by chemotherapy (CT) is increasing. CT-induced nausea and vomiting negatively impact patient quality of life.

The primary objective of the trial is to evaluate against a placebo the efficacy of Cocculine® administered as an adjunct to conventional treatments (corticosteroids and 5-HT3 receptor antagonists) for the management of nausea induced by a 1st course of adjuvant CT with FAC50, FEC100 or TAC in patients with non-metastatic breast cancer.

Secondary objectives are to test:

* the persistence of Cocculine® efficacy over the 2nd and 3rd CT courses
* the contribution of Cocculine® to the global management of nausea and vomiting during adjuvant CT
* patient compliance with Cocculine® dose.

Eligible patients will be randomly assigned to one of 2 arms: Cocculine® or placebo.

Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.

Placebo-controlled Evaluation of Homeopathic Remedy (Cocculine®) Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer.

BOIRON

Centre Leon Berard

Zora ABDELBOST

Anti-Infective Agents

Metronidazole

This arm consists of providing patients with a personalized coaching focused on exercise and physical activity, with or without connected watch.

The standard supportive approach will consist in recommendations made during visits with the oncologist. The delivery of post-treatment care by oncologists and their team systematically provide exercise advice patients including recommendations for strength training and aerobic activity.

Patients will receive personalized physical activity coaching with an online digital platform to take online educational workshops and interact with other peers of the cohort with a online private forum. They will also have a connected watch that will measure several physical activity metrics.

Personalized Coaching (Arm A)

Patients will receive the standard recommendations during their visits with the oncologist. The exercise recommendations include strength training and aerobic activities.

Standard supportive approach (Arm B)

Laurence VANLEMMENS, MD

A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

A multicentric, phase III, randomized open-labelled study with two parallel groups which evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

Other objectives include:

* To evaluate the impact of the intervention on each dimension of the SF-36 at 12 months
* To evaluate the impact of the program on the health-related quality of life over time
* To evaluate the impact of the program on the practice of exercise and physical activity (EPA) at the recommended intensity (30min of moderate EPA, 5 days/week)
* To evaluate the impact of the program on:

  o fatigue, pain, depression, sleep, motivation for the practice, self-respect, biometric measures (including fat mass and lean mass), physical capacities, patient's satisfaction regarding the assigned program, occurrence of Adverse Events (AE) related to the treatment, professional life for patients who worked before the announcement of getting cancer and psychotropic and analgesic drug intake
* To evaluate the compliance to the program through the engagement score during the first 4 months (in the experimental group).
* To evaluate the impact of the program in terms of disease-free survival

Additional objectives on health economics include:

* To evaluate the efficiency of the personalized remote exercise and physical activity coaching compared with the standard supportive approach in BC survivors treated in an adjuvant setting.
* To characterize the health-state utility of BC survivors over time; assessing the association of change in health-utility with changes in other variables such as exercise and physical activity.

Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients

Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer

This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: PCS (Physical Component Summary)

This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: MCS (Mental Component Summary)

For each summary score (PCS and MCS) separately, the success or failure score will be calculated :

* For patients with an intermediate or good QoL at baseline (summary score≥50), failure is defined as a score decrease ≥ 5 points whereas a stable measure (difference of less than 5 points) and improvement of ≥ 5 points will be classified as a success.
* For patients with a relatively poor QoL at baseline (summary score \<50), success is defined as a score increase of 5 points or more at 12 months. All other cases are classified as a failure.

The HRQoL evaluated with the Short-Form-36 questionnaire. We chose the SF-36 generic questionnaire to assess HRQoL of these patients instead of a cancer-specific HRQoL questionnaire such as the EORTC QLQ-C30. In fact, the QLQ-C30 as well as majority of cancer-specific questionnaires is focused on symptoms and side effects such as nausea and vomiting, which are not relevant for cancer survivorship. Thus, patients will not concerned by these items. The creation of an EORTC cancer survivorship questionnaire is ongoing, but this questionnaire is not validated yet at the time of the start of this study. Thus, a generic questionnaire, the SF-36, was considered as more relevant and sensitive to change for these patients.

The EPA will be evaluated with the Global Physical Activity Questionnaire for the patient's subjective measure and with the connected watch in the experimental arm for the objective measure.

The Global Physical Activity Questionnaire is an instrument to assess physical activity. It was developed under the auspices of the WHO in 2002. GPAQ comprises 19 questions grouped to capture physical activity undertaken in different behavioral domains, these are work, transport and discretionary (also known as leisure or recreation). Within the work and discretionary domains, questions assess the frequency and duration of 2 differents categories of activity defined by the energy requirement or intensity. In the transport domain, the frequency and duration of all walking and cycling is captured but no attempt is made to differentiate between these activities. One additional item collected time spent in sedentary activities.

Will be evaluated with the Brief Fatigue Inventory auto-questionnaire The Brief Fatigue Inventory (BFI) is a questionnaire uses an 11-point scale (0 to 10) to measure the specific symptom of cancer-related fatigue in a single dimension. Nine items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue". Cut points for fatigue severity are defined in two categories: a "fatigue worst" rating of 7 or greater indicates "severe" and 0 to 6 indicates "non-severe." Six additional items describe how much fatigue has interfered with different aspects of the patient's life during the past 24 hours. These items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relationships with other people, and enjoyment life.

Will be evaluated with the Brief Pain Inventory-SF (Brief Pain Inventory-short form) auto-questionnaire The Brief Pain Inventory - Short Form (BPI-sf) is used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. It is a 9 item self-administered questionnaire. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.

Will be evaluated with the Hospital Anxiety and Depression Scale auto-questionnaire The Hospital Anxiety and Depression Scale (HADS) is a self-administrated questionnaire to detect anxiety and depressive disorders, validated in French with a general population and suffering from cancer. It has 14 items with 4 answers proposed and each correspond to a score between 0 to 3. Seven questions relate to anxiety and seven others to depressive dimension, thus allowing two scores to be obtained (maximum score of each score = 21). For subscales, a score of 0 to 7 is an absence of disorders (anxiety or depressive, depending on the subscale), 8 to 10 to a suspected disorder and 11 to 21 to a proven disorder.

Sleep will be evaluated in both arms using the Pittsburgh Sleep ≥Index (PSQI). In the experimental group, the number of hours of light and deep sleep will also be collected (connected watch).

The Pittsburgh Sleep Quality Index (PSQI) is designed to measure sleep quality over a onemonth interval. It includes 19 self-rated questions that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Component scores (range 0 to 3) are summed to provide a global sleep quality score (range 0 to 21); a score greater than five indicates poor sleep quality.

Will be evaluated with the weight, BMI, fat mass, lean mass, waist size and hip size.

These multiple measurements will be aggregated to arrive at one reported value, for exemple BMI.

Will be evaluated through differents physical exercices, for exemple:

* Chair test (resistance test of lower limbs)
* Weight test (resistance test of upper limbs)
* Hand grip test (gripping force)
* Goniometer test (flexibility of upper limbs)
* Test of unipodal support (balance)
* 6-min walking test
* Heart rate by telemetry (Beating per minute - cardiac rhythm)
* Borg Rating of Perceived Exertion Scale And these multiple measurements will be aggregated to arrive at one reported value.

Adverse Events graded according to NCI-CTC-AE v5, considering all types of AE, related to the evaluated program or to concomitant/previous anti-cancer treatments

Professional activity status before diagnosis and after anti-cancer treatment (temporary interruption, partial time work...).

At baseline and during the follow-up, record the professional staut of the patients to provide the statistical trend regarding the professional activities.

Will be evaluated with the frequency of psychotropic (including hypnotic) and analgesic intake

Disease-free survival defined as the time between randomization and relapse or death from any cause.

Using EQ-5D and EQ VAS (study entry, M4, M8 and M12) and direct medical costs from inclusion up the M12.

The descriptive system comprises five dimensions. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate her health state by ticking in the box against the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for five dimensions can be combined in a 5-digit number describing the respondent's health state (for instance, " 11111 " corresponding to the perfect health).

The EQ VAS records the respondent's self-rated health on a 20 cm vertical (graduate 0 to 100), visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.

Stimulab

Centre Oscar Lambret

Hypoglycemic Agents

Metformin

Non Diabetic metastatic breast cancer Patients will take metformin 1 gm. twice daily (Nathan 2009) along with standard chemotherapy

Non Diabetic metastatic breast cancer Patients will take standard chemotherapy only

determine the effect of metformin along with standard chemotherapy

Metformin plus chemotherapy

Chemotherapy

ahmed a berry, PhD

ahmed h shaaban, MD

hoda m rabea, PhD

This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.

the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.

Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment

The Response Evaluation Criteria in Solid Tumors (RECIST 1.1) was used to evaluate the response to chemotherapy alone in case of control arm and chemotherapy plus metformin in case of drug arm for breast cancer with distant metastasis

the time period from the start of trial till death or end of follow-up

from the time between start of the trial and recurrence or disease progression, or end of follow-up

measure blood Insulin Growth like Factor -1 (IGF-1) at the begining of trial then after 3 months at the end of 3 cycles (each cycle arround 28 days )

Hager salah el din

pharmacist

Pathologic Complete Response

Disease Progression

Disease Attributes

12 days session of physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers

dietary counseling by a dietetician in the anticancer hospital

12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers

dietaty education, physical training, physiotherapy and SPA cares

Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.

The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.

Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy

Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care

Quality of life was measured with the SF36 questionnaire before randomization, at 6, 12, 18, 24 and 36 months. The difference at one year was the main endpoint.

HAD questionnaire is a validated instrument that complete the SF36 QoL questionnaire.

Weight(kg), impedancemetry, hip/waist circumference are needed to characterize eventual weight changes in both allocation groups

6 questions are asked: it rates the delay before sleep onset, the lenght of sleep, the number of awakening, the lenght of wake periods during the night, the concentration/alertness after sleep, and the fatigue in the morning.

health related costs, health insurance costs, social costs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biological Response to Tamoxifen (TAM) in Patients With Breast Cancer Non Metastatic RH+	NCT01220076	Non Metastatic ...	tamoxifen	18 Years -	Institut Cancerologie de l'Ouest
The Impact of Oncoplastic Breast Surgery on the Oncological Safety and Patient Satisfaction	NCT02901223	Non Metastatic ...	Standard quadra... oncoplastic bre...	- 60 Years	Ain Shams University
Placebo-controlled Evaluation of Cocculine® Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer.	NCT00409071	Breast Cancer	Cocculine® placebo	18 Years -	Centre Leon Berard
Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients	NCT04536584	Breast Cancer F...	Personalized Co... Standard suppor...	18 Years -	Centre Oscar Lambret
Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment	NCT04143282	Metastatic Brea...	Metformin plus ... Chemotherapy	18 Years - 75 Years	Beni-Suef University
Support and Rehabilitation Protocol for Non Metastatic Breast Cancer Patients in Complete Remission After Chemotherapy	NCT01563588	Non Metastatic ...	dietaty educati...	18 Years - 70 Years	Centre Jean Perrin

Spots Global Cancer Trial Database for non metastatic breast cancer