Current Clinical Trials

Breast Cancer WEight Loss Study (BWEL Study)
  1. Constantin Dasanu, MD, PhD
    Constantin Dasanu, MD, PhD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started July 2017
  5. Constantin Dasanu, MD, PhD
  6. Currently not accepting new patients

Description

Summary

Obesity is a growing health problem in the United States and, increasingly, around the world. Excess body weight has been linked to an increased risk of postmenopausal breast cancer and triple-negative premenopausal breast cancer. Growing evidence also suggests that obesity is associated with poor prognosis in women diagnosed with early-stage breast cancer. Dozens of studies demonstrate that women who are overweight or obese at the time of breast cancer diagnosis are at increased risk of cancer recurrence and death as compared to leaner women; some evidence suggests that women who gain weight after a breast cancer diagnosis may also be at increased risk of poor outcomes but this evidence is inconsistent. However, despite the large body of observational data supporting a relationship between weight and breast cancer prognosis, there is little information regarding the impact of weight loss upon the risk of recurrence and death in women with early-stage breast cancer. Given that weight is a potentially modifiable factor, further work is needed to determine if weight loss could be an effective strategy to improve prognosis in women with early stage breast cancer.

Official Title

A011401 (BWEL Weight Loss Trial): A randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer.

Detailed Description

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... more
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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 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. To evaluate the effect of a supervised weight loss intervention upon: Overall survival Distant disease free survival Weight Body composition (as measured by waist and hip circumference) Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease 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. 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

Eligibility

for people 18 Years and up
Documentation of Disease: 1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 14 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 evidenc... more
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Documentation of Disease: 1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 14 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 T0N0, T1N0, T2N0 or T1N1mi and T2N1mi 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. 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.

Lead Scientists at Eisenhower Health

Constantin Dasanu, MD, PhD
Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicin... more
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Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicine in New York and his fellowship in Hematology/Oncology at New York Medical College. Dr. Dasanu also completed his training in Hematology & Transfusion Medicine in his home country Romania. 

“My immunology background offers me a unique clinical perspective as contemporary cancer therapies include a multitude of targeted agents, monoclonal antibodies, various biologics and vaccines,” states Dr. Dasanu. He treats patients with a variety of solid cancers, malignant melanoma and blood conditions. He serves as Director of Hematologic Malignancies at Eisenhower Lucy Curci Cancer Center (ELCCC). 

Dr. Dasanu is a Clinical Professor of Medicine at the University of California in San Diego, a major collaborative affiliate of ELCCC. He is the Director of Research at ELCCC and a principal investigator for a number of clinical trials. He presents his research findings at national and international conferences. He is the recipient of several teaching awards including the prestigious Thomas R. Preston MD Excellence in Teaching Award at the University of Connecticut in 2011. 

A prolific medical writer, Dr. Dasanu published more than 200 scientific and scholarly articles in prominent specialty journals including Journal of Clinical Oncology, New England Journal of Medicine, Journal of Thoracic Oncology and British Journal of Haematology among others. He is the editor of oncology sections at the Expert Opinion on Pharmacotherapy, Expert Opinion on Biological Therapy, and Current Medical Research and Opinion. He is a peer reviewer for Blood Journal and Leukemia Research. 

Armed with the knowledge of science, Dr. Dasanu feels that he can make a real difference in the lives of his patients. “The field is constantly changing and, therefore, I keep learning and constantly applying the most up-to-date, state-of-the-art treatments which ultimately benefit my patients,” states Dr. Dasanu. “My role is one of providing my patients with a medical plan that offers hope, but not false hope. Treating patients as unique individuals, with respect and compassion, and treating them as I would want to be treated are my ultimate goals in patient care.”

Clinical Study Details

  1. Currently not accepting new patients
  2. study started July 2017
  3. Interventional
  4. April 04, 2024