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The Impact of Obesity and Obesity Treatments on Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00933309
First received: July 3, 2009
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.


Condition Intervention Phase
Breast Cancer
Drug: Exemestane
Drug: Avandamet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Obesity and Obesity Treatments on Breast Cancer: A Phase I Trial of Exemestane With Metformin and Rosiglitazone for Postmenopausal Obese Women With ER+ Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Dose-limiting toxicity (DLT) [ Time Frame: Day 1 of each cycle ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 2009
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Exemestane alone
Drug: Exemestane
25 mg tablets orally once a day
Other Name: Aromasin®
Experimental: Group 2
Exemestane plus Avandamet
Drug: Exemestane
25 mg tablets orally once a day
Other Name: Aromasin®
Drug: Avandamet
Beginning dose 2 mg rosiglitazone with 500 mg metformin hydrochloride (2mg/500 mg) tablets taken orally once a day
Other Names:
  • Metformin plus rosiglitazone
  • Rosiglitazone and Metformin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Overweight or obese postmenopausal women with a history of biopsy-proven estrogen receptor positive and/or progesterone receptor positive breast cancer and clinical evidence of metastatic disease. Overweight and obesity are defined by the WHO as a BMI of 25 - 29.9 and >/= 30 kg/m^2 respectively. Postmenopausal status is defined by one of the following: a) no spontaneous menses for over 1 year, in women >55 years; Continued in inclusion criterion # 2.
  2. Continuation from inclusion #1: b) no spontaneous menses within the past 1 year in women </= 55 years with postmenopausal gonadotrophin levels (LH and FSH levels > 40 IU/L) or postmenopausal estradiol levels (<10 pg/mL); or c) bilateral oophorectomy.
  3. Prior endocrine therapy, biologic therapy and chemotherapy are allowed, either in the adjuvant setting or for metastatic breast cancer.
  4. Prior exemestane, metformin, or rosiglitazone is allowed if taken longer than 7 days prior to enrollment.
  5. Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of study medications.
  6. Performance status </= 2 ECOG.
  7. Absolute neutrophil count (ANC) >/= 1000/µl, platelets >/= 75,000/µl, hemoglobin >/= 8.5 gm/dL; serum creatinine < 1.4 mg/dL; bilirubin < 1.8 mg/dL; ALT or AST </= 2.5 x ULN if no demonstrable liver metastases or </= 5 x ULN in presence of liver metastases; alkaline phosphatase < 3 x upper limit of normal; calcium </= 11.0 mg/dL.
  8. Patients must be competent to give informed consent and to state that they understand the investigational nature of the proposed treatment.

Exclusion Criteria:

  1. Extensive radiotherapy within previous 4 weeks (greater than or equal to 30% of marrow-bearing bone, e.g., whole pelvis or half spine).
  2. Uncontrolled diabetes mellitus (hemoglobin A1C > 9 or random plasma glucose > 400 mg/dL).
  3. History of acromegaly, Cushing's syndrome, Cushing's disease, Addison's disease (treated or untreated).
  4. Patients with unstable angina, uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification).
  5. Concurrently receiving and are unwilling to discontinue hormonal (estrogen with or without progesterone) replacement therapy.
  6. Other investigational drugs within the past 3 weeks or concurrently.
  7. Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  8. Laboratory results sustained at: International normalized ratio (INR) > 1.6; ALT or AST > 2.5 x ULN if no demonstrable liver metastases or > 5 x ULN in presence of liver metastasis; No more than 3 retests within screening period
  9. Patients with known diagnosis of human immunodeficiency virus (HIV) infection.
  10. Patients who received chemotherapy within 3 weeks (6 weeks for nitrosourea or mitomycin-C). Acute toxicities from prior therapy must have resolved to Grade </= 1 with the exception of fatigue, alopecia, or anemia.
  11. Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol e.g., severe renal or hepatic impairment or currently unstable or uncompensated respiratory or cardiac conditions.
  12. History of hypersensitivity to active or inactive excipients of the study medications - exemestane or metformin.
  13. Untreated or clinically unstable central nervous system involvement. A patient with adequately treated brain metastases would be eligible one month after completion of surgery and/or radiation therapy if she is clinically stable.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933309

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Susan G. Komen Breast Cancer Foundation
Investigators
Study Chair: Francisco J. Esteva, MD, PhD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00933309     History of Changes
Other Study ID Numbers: 2008-0284
Study First Received: July 3, 2009
Last Updated: August 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast
Obese
Obesity Treatment
Exemestane
Aromasin
Metformin and Rosiglitazone
Avandamet
Postmenopausal
Hormone-sensitive
Hormone-receptive-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Body Weight
Breast Diseases
Neoplasms
Neoplasms by Site
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Skin Diseases
Exemestane
Metformin
Rosiglitazone
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014