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Weight Loss Intervention for Breast Cancer Recurrence Prevention
Study Summary
This trial tests if weight loss prevents breast cancer from recurring in overweight and obese women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your body mass index (BMI) is 27 or higher, as measured within the last 56 days before joining the study.I haven't had any cancer except highly curable types in the last 4 years.I have not had, nor plan to have, weight-loss surgery in the next 2 years.I have had a condition where my lymphocytes grow abnormally.My cancer is not HER2 positive based on specific tests.I do not have any health conditions that would shorten my life to under 5 years.I am receiving chemotherapy chosen by my doctor for triple-negative breast cancer.I have a history of cancer.I haven't had any cancer except for skin cancer in the last 5 years.My cancer has not spread to other parts of my body.I do not take insulin or sulfonylureas for diabetes.I do not have serious digestive problems that would stop me from following a study diet.I am currently on hormone, biologic, or bone-strengthening therapy.I can walk at least 2 blocks without help.I don't have severe heart, lung, or muscle diseases that stop me from doing moderate exercise.My cancer was confirmed through a biopsy or during my first cancer-related surgery.My cancer has not spread to other parts of my body.I was diagnosed with invasive breast cancer less than 14 months ago.You have had certain medical tests done between when you were first diagnosed and when you joined the study.I must get chemotherapy for my ER/PR+ cancer unless tests show low or medium risk of it coming back with just hormone therapy.I have had a sentinel lymph node biopsy or axillary lymph node dissection.I have been on hormone therapy for breast cancer for at least 5 years.I am fully active or can carry out light work.Before my chemotherapy and surgery, my cancer had not spread to nearby tissues.I have cancer in both breasts, diagnosed within 3 months of each other, and at least one meets the trial criteria.I must get chemotherapy unless a test shows I'm at low risk with hormone therapy alone.I have cancer in both breasts, diagnosed within 3 months of each other, and at least one meets the trial's criteria.My breast cancer is at a specific stage and has certain hormone receptor characteristics.I have had a mammogram of both breasts or the remaining breast if I had a mastectomy, within the last year.My cancer is HER2-negative, not suitable for HER2-targeted treatments.I haven't had invasive breast cancer in the last 5 years, except for my current diagnosis.I finished all my cancer treatments like chemotherapy, radiation, and surgery over 3 weeks ago.I had my breast cancer surgery at least 21 days before signing up.My surgery removed all the invasive cancer.I don't have serious digestive issues that would stop me from following the study diet.I am 18 years old or older.I am a woman.I am a woman.I can walk at least 2 blocks at any pace.
- Group 1: Arm 2: Health Education Program + Weight Loss Intervention
- Group 2: Arm 1: Health Education Program
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
At how many total locations is this trial currently being conducted?
"Patients are currently being enrolled at this trial's 4 primary locations: Cancer Center of Kansas - Dodge City in Dodge City, Kansas; Saint Joseph Hospital East in Lexington, Kentucky; Allegiance Health in Jackson, Michigan. In addition, there are 100 other centres where recruitment is happening."
Has this medication been granted permission by the FDA for general use?
"This therapy is considered safe, as it has progressed to Phase 3 clinical trials. This suggests that not only is there evidence of its efficacy, but also that multiple rounds of testing have verified its safety."
Are there any more places available for people who want to participate in this research?
"Unfortunately, this particular study is no longer actively recruiting patients. Although the original posting was on August 1st, 2016, the most recent edit was done on November 11th, 2021. That being said, there are 2,589 other trials that are still looking for participants."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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