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A Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

Clinical Trial Details

This study is being done to see if losing weight may help prevent breast cancer from coming back (recurring). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. At this time we do not know whether or not losing weight will reduce the risk of breast cancer returning. This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost. 

There will be about 3,000 women taking part in this study. 

This study has two study groups. 

  • Group 1 will get a Health Education program that is designed to give women more information about their breast cancer, as well as general information about their general health. 
  • Group 2 will get the Health Education program and will also get a 2-year weight loss program. This program will be designed to help women lose about 10% of their starting weight by decreasing the calories they eat and by increasing their exercise. 
Key Eligibility: 
  • Participants must be women 18 years or older 
  • Must register to this study within 12 months after first invasive breast cancer diagnosis 
  • Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery 
  • Breast cancer in both breasts is allowed as long as diagnosis was made within 30 months of one another and at least one of the two breast cancers meet eligibility criteria and neither is HER2 positive or inflammatory 
  • HER2 negative 
  • ER and PR negative or ER and/or PR positive 
  • No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis 
  • Must have had a bilateral mammogram within 12 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. Subjects with bilateral total mastectomies do not require imaging 
  • Investigations, including chest X-ray or CT chest, bone scan and abdominal ultrasound or liver scan or CT abdomen have been performed between the first diagnosis and time of registration as detailed when you contact the study team
  • All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration
  • Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable
  • All subjects must have sentinel node biopsy and/or axillary node dissection
  • All women who undergo breast conserving therapy must receive concomitant radiotherapy
  • Subjects with hormone receptor positive breast cancer must plan to receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Marta Vallee Cobham, RN, BSN
(212) 821-0780
mac2034@med.cornell.edu

Brooklyn

Contact(s)

Tricia L. Ellis
(718) 330-7441
tre2004@nyp.org

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1711018735

ClinicalTrials.gov:

NCT02750826

Sponsor:

A011401

Status

Open to Enrollment

Age Group

Adult

Sponsor