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Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

Summary

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.

Official Title

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

Details

This randomized controlled trial of weight loss interventions in overweight and obese women with early stage breast cancer consists of two arms, please see the arms section for more information. Patients will be randomized 1:1 within stratification factors: menopausal status (premenopausal vs. postmenopausal), hormone receptor status of the tumor (ER and/or PR positive vs. ER and PR negative), and race/ethnicity (African American vs. Hispanic vs. Other). The primary objective of this trial is to compare the effect of the telephone-based intervention versus a health educational control on invasive disease-free survival (IDFS). The total sample size is 3136 patients. Patient follow up for primary and secondary endpoints will continue to a maximum of 10 years, as per the standard protocol for cooperative group adjuvant trials.

The primary and secondary objectives of the study:

Primary objective To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (IDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.

Secondary objectives

  1. To determine the relationship between changes in weight and IDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention.
  2. To evaluate the effect of a supervised weight loss intervention upon:
  3. Overall survival
  4. Distant disease free survival
  5. Weight
  6. Body composition (as measured by waist and hip circumference)
  7. Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease
  8. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative breast cancer.
  9. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women.

Patients are to be followed every 6 months for the first 3 years after study enrollment and then annually until 10 years from registration. The intervention will last 2 years or until disease recurrence/progression, new invasive primary cancer as defined in the protocol or patient withdrawal.

Keywords

Breast Carcinoma Weight Loss Breast Neoplasms

Eligibility

For females ages 18 years and up

  1. 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 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.

1.3 Eligible tumor-node-metastasis (TNM) Stages include:

  • Estrogen receptor (ER) and Progesterone receptor (PR) negative (defined as <1%staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3. Note: Patients with T1,N1mi disease are NOT eligible.
  • ER and/or PR positive (defined as ≥ 1% staining for ER and/or PR on IHC):

T0-3N1-3 or T3N0. Note: Patients with T1-2, N1mi disease are NOT eligible

  • The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical(c)TNM or pathologic (yp)TNM. The same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapy.

1.4 No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable).

1.5 Patients 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).

1.6 Investigations, including chest X-ray or computed tomography (CT) chest, bone scan(with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration as detailed below.

  • Chest X-Ray, 2 view (or Chest CT, or positron emission tomography [PET]/CT) is mandatory
  • Bone scans (with x-rays of abnormal areas) are required only if alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
  • Abdominal imaging is required only if ALT, AST or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
  • Prior Treatment

2.1 All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration.

2.2 All triple negative patients must receive chemotherapy of the treating physician's choice.

2.3 ER/PR+ patients must receive chemotherapy (of the treating physician's choice)unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone.

2.4 Patients may have breast reconstruction during protocol participation, but definitive breast cancer surgery must be completed at least 21 days prior to registration.

Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable.

2.5 Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins,further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered. In situ lobular disease at the margin is acceptable.

2.6 All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. Sentinel lymph node biopsy alone is allowed in the following instances:

  • Sentinel lymph node biopsy is negative: pN0
  • Sentinel lymph node biopsy is positive for isolated tumor cells only:

pN0 (i+)

  • Clinically node negative, T1-2 tumors with sentinel lymph node biopsy positive in< 2 lymph nodes without matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation, or undergoing mastectomy and chest wall irradiation.
  • For patients who had a positive node prior to neoadjuvant chemotherapy, sentinel node alone is allowed after neoadjuvant therapy if:
  • Sentinel node biopsy is negative after chemotherapy and either at least 2 sentinel nodes were removed or a clip was placed in the involved node prior to treatment.
  • =< 2 lymph nodes are positive for cancer and the patient is participating in A011202
  • All women who undergo breast conserving therapy must receive concomitant radiotherapy. Radiation after mastectomy is to be administered according to prespecified institutional guidelines. Radiation must be completed at least 21 days prior to registration.
  • Patients with hormone receptor positive breast cancer as defined above must 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. (NOTE:for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required). Hormonal therapy can be initiated prior to or during protocol therapy.
  • Participants must be women
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Comorbid Conditions

6.1 No history of other malignancy within the past 4 years, except for malignancies with a >95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer). Patients cannot have metastatic breast or other cancer.

6.2 No diabetes mellitus currently treated with insulin or sulfonylureas.

6.3 No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.

6.4 No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.

6.5 No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration.

6.6 No comorbid conditions that would cause life expectancy of less than 5 years.

6.7 No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.

  1. Other

7.1 BMI ≥27 kg/m2 documented within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is <27 then the patient is not eligible to enroll.

7.2 Self-reported ability to walk at least 2 blocks (at any pace).

7.3 Not participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed.Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.

7.4 Able to read and comprehend English. Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read lifestyle intervention materials and communicate with a coach through 42 phone calls over 2 years. The study team plans to make the intervention available in Spanish in the future.

Locations

  • UCSF Medical Center-Mount Zion accepting new patients
    San Francisco, California, 94115, United States
  • California Pacific Medical Center-Pacific Campus accepting new patients
    San Francisco, California, 94115, United States
  • Kaiser Permanente-San Francisco accepting new patients
    San Francisco, California, 94115, United States
  • Kaiser Permanente accepting new patients
    Fresno, California, 93720, United States
  • Kaiser Permanente-South San Francisco accepting new patients
    South San Francisco, California, 94080, United States
  • Bay Area Breast Surgeons Inc accepting new patients
    Emeryville, California, 94608, United States
  • Epic Care Partners in Cancer Care accepting new patients
    Emeryville, California, 94608, United States
  • Alta Bates Summit Medical Center - Summit Campus accepting new patients
    Oakland, California, 94609, United States
  • Bay Area Tumor Institute accepting new patients
    Oakland, California, 94609, United States
  • Alta Bates Summit Medical Center-Herrick Campus accepting new patients
    Berkeley, California, 94704, United States
  • Kaiser Permanente-Richmond accepting new patients
    Richmond, California, 94801, United States
  • Mills-Peninsula Medical Center accepting new patients
    Burlingame, California, 94010, United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland, California, 94611, United States
  • Kaiser Permanente San Leandro accepting new patients
    San Leandro, California, 94577, United States
  • Kaiser Permanente-San Rafael accepting new patients
    San Rafael, California, 94903, United States
  • Eden Hospital Medical Center accepting new patients
    Castro Valley, California, 94546, United States
  • Contra Costa Regional Medical Center accepting new patients
    Martinez, California, 94553-3156, United States
  • Kaiser Permanente-Redwood City accepting new patients
    Redwood City, California, 94063, United States
  • Kaiser Permanente-Walnut Creek accepting new patients
    Walnut Creek, California, 94596, United States
  • Sutter Cancer Research Consortium accepting new patients
    Novato, California, 94945, United States
  • Palo Alto Medical Foundation Health Care accepting new patients
    Palo Alto, California, 94301, United States
  • Kaiser Permanente-Vallejo accepting new patients
    Vallejo, California, 94589, United States
  • Sutter Solano Medical Center/Cancer Center accepting new patients
    Vallejo, California, 94589, United States
  • Epic Care-Dublin accepting new patients
    Dublin, California, 94568, United States
  • Kaiser Permanente-Fremont accepting new patients
    Fremont, California, 94538, United States
  • Palo Alto Medical Foundation-Fremont accepting new patients
    Fremont, California, 94538, United States
  • Palo Alto Medical Foundation-Camino Division accepting new patients
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology accepting new patients
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Sunnyvale accepting new patients
    Sunnyvale, California, 94086, United States
  • Kaiser Permanente Medical Center - Santa Clara accepting new patients
    Santa Clara, California, 95051, United States
  • Kaiser Permanente-Deer Valley Medical Center accepting new patients
    Antioch, California, 94531, United States
  • Northbay Cancer Center accepting new patients
    Vacaville, California, 95687, United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville accepting new patients
    Vacaville, California, 95687, United States
  • Kaiser Permanente Medical Center-Vacaville accepting new patients
    Vacaville, California, 95688, United States
  • Saint Helena Hospital accepting new patients
    Saint Helena, California, 94574, United States
  • Kaiser Permanente-Santa Teresa-San Jose accepting new patients
    San Jose, California, 95119, United States
  • Kaiser Permanente-Santa Rosa accepting new patients
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation accepting new patients
    Santa Rosa, California, 95403, United States
  • Palo Alto Medical Foundation-Santa Cruz accepting new patients
    Santa Cruz, California, 95065, United States
  • Kaiser Permanente-Stockton accepting new patients
    Stockton, California, 95210, United States
  • Sutter Davis Hospital accepting new patients
    Davis, California, 95616, United States
  • Kaiser Permanente-South Sacramento accepting new patients
    Sacramento, California, 95823, United States
  • Sutter Medical Center Sacramento accepting new patients
    Sacramento, California, 95816, United States
  • Kaiser Permanente-Modesto accepting new patients
    Modesto, California, 95356, United States
  • Kaiser Permanente - Sacramento accepting new patients
    Sacramento, California, 95825, United States
  • Memorial Medical Center accepting new patients
    Modesto, California, 95355, United States
  • Kaiser Permanente-Roseville accepting new patients
    Roseville, California, 95661, United States
  • Sutter Cancer Centers Radiation Oncology Services-Roseville accepting new patients
    Roseville, California, 95661, United States
  • Sutter Roseville Medical Center accepting new patients
    Roseville, California, 95661, United States
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park accepting new patients
    Cameron Park, California, 95682, United States
  • Sutter Cancer Centers Radiation Oncology Services-Auburn accepting new patients
    Auburn, California, 95603, United States
  • Sutter Auburn Faith Hospital accepting new patients
    Auburn, California, 95602, United States
  • PCR Oncology accepting new patients
    Pismo Beach, California, 93449, United States
  • Feather River Cancer Center accepting new patients
    Paradise, California, 95969, United States
  • Carson Tahoe Regional Medical Center accepting new patients
    Carson City, Nevada, 89703, United States
  • Renown Regional Medical Center accepting new patients
    Reno, Nevada, 89502, United States
  • Saint Mary's Regional Medical Center accepting new patients
    Reno, Nevada, 89503, United States
  • Kaiser Permanente - Panorama City accepting new patients
    Panorama City, California, 91402, United States
  • Kaiser Permanente accepting new patients
    Woodland Hills, California, 91367, United States
  • Mercy Regional Cancer Center accepting new patients
    Redding, California, 96001, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center accepting new patients
    Burbank, California, 91505, United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles, California, 90027, United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • Huntington Memorial Hospital accepting new patients
    Pasadena, California, 91105, United States
  • Kaiser Permanente-Cadillac accepting new patients
    Los Angeles, California, 90034, United States
  • Kaiser Permanente-Baldwin Park accepting new patients
    Baldwin Park, California, 91706, United States
  • Presbyterian Intercommunity Hospital accepting new patients
    Whittier, California, 90602, United States
  • Pomona Valley Hospital Medical Center accepting new patients
    Pomona, California, 91767, United States
  • Kaiser Permanente-Bellflower accepting new patients
    Bellflower, California, 90706, United States
  • Kaiser Permanente - Harbor City accepting new patients
    Harbor City, California, 90710, United States
  • Kaiser Permanente Hospital accepting new patients
    Fontana, California, 92335, United States
  • Kaiser Permanente-Anaheim accepting new patients
    Anaheim, California, 92807, United States
  • Saint Joseph Hospital - Orange accepting new patients
    Orange, California, 92868, United States
  • Kaiser Permanente-Riverside accepting new patients
    Riverside, California, 92505, United States
  • Kaiser Permanente-Irvine accepting new patients
    Irvine, California, 92618, United States
  • Comprehensive Cancer Centers of Nevada-Summerlin accepting new patients
    Las Vegas, Nevada, 89144, United States
  • Summerlin Hospital Medical Center accepting new patients
    Las Vegas, Nevada, 89144, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills accepting new patients
    Las Vegas, Nevada, 89149, United States
  • Ann M Wierman MD LTD accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Cancer and Blood Specialists-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada - Northwest accepting new patients
    Las Vegas, Nevada, 89128, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya accepting new patients
    Las Vegas, Nevada, 89128, United States
  • Las Vegas Cancer Center-Medical Center accepting new patients
    Las Vegas, Nevada, 89148-2405, United States
  • 21st Century Oncology - Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Nevada Cancer Specialists-Fort Apache accepting new patients
    Las Vegas, Nevada, 89148, United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin accepting new patients
    Las Vegas, Nevada, 89113, United States
  • University Medical Center of Southern Nevada accepting new patients
    Las Vegas, Nevada, 89102, United States
  • Cancer and Blood Specialists-Shadow accepting new patients
    Las Vegas, Nevada, 89106, United States
  • Radiation Oncology Centers of Nevada Central accepting new patients
    Las Vegas, Nevada, 89106, United States
  • 21st Century Oncology - Vegas Tenaya accepting new patients
    Las Vegas, Nevada, 89182, United States
  • 21st Century Oncology accepting new patients
    Las Vegas, Nevada, 89109, United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Sunrise Hospital and Medical Center accepting new patients
    Las Vegas, Nevada, 89109, United States
  • Comprehensive Cancer Centers of Nevada - Central Valley accepting new patients
    Las Vegas, Nevada, 89169, United States
  • University Cancer Center accepting new patients
    Las Vegas, Nevada, 89169, United States
  • Radiation Oncology Centers of Nevada Southeast accepting new patients
    Las Vegas, Nevada, 89119, United States
  • Cancer and Blood Specialists-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Comprehensive Cancer Centers of Nevada - Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Las Vegas Cancer Center-Henderson accepting new patients
    Henderson, Nevada, 89052, United States
  • Cancer Therapy and Integrative Medicine accepting new patients
    Las Vegas, Nevada, 89121, United States
  • 21st Century Oncology - Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson accepting new patients
    Henderson, Nevada, 89074, United States
  • Desert Regional Medical Center accepting new patients
    Palm Springs, California, 92262, United States
  • Eisenhower Medical Center accepting new patients
    Rancho Mirage, California, 92270, United States
  • Kaiser Permanente-San Marcos accepting new patients
    San Marcos, California, 92069, United States

Details

Status
accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT02750826
Phase
Phase 3
Study Type
Interventional
Last Updated
September 29, 2017
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