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Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer
 
Region Sponsors
Colorado
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
CO-16-2418
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Breast Carcinoma
 
Purpose
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). 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. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
 
Detailed Description
 
Gender Age Limit
Female
 
Inclusion Criteria
  • Documentation of Disease: 1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer.
  • A core biopsy interpreted as invasive cancer meets this criterion, if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy).
  • Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery
  • Eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery, if a patient is eligible based on either, they are eligible for the study.
  • Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither Her-2 positive or inflammatory.
  • No evidence of metastatic disease
  • 1.2 Her-2 negative, defined as: In-situ hybridization (ISH) ratio of < 2.0 (if performed), Immunohistochemistry (IHC) staining of 0-2+ (if performed), Deemed to not be a candidate for Her-2 directed therapy.
  • Please Contact Study Coordinator for more inclusion criteria
 
Exclusion Criteria
  • N/A

 
Keywords and/or Specific Medical Conditions
  • Breast Carcinoma
  • Oncology (Adult)
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex R Menter, MD
Contact Information:
- Jordan Zach
-303-915-3872
-Jordan.A.Zach@kp.org
-Franklin Medical Offices - Denver


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