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Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

Primary Purpose

Breast Cancer, Hot Flashes, Menopausal Symptoms

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
conjugated estrogens
medroxyprogesterone
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, breast cancer in situ, ductal breast carcinoma, hot flashes, menopausal symptoms

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed node-negative invasive carcinoma or ductal carcinoma in situ of the breast No contralateral breast cancer No recurrent or metastatic disease Completion of active non-hormonal therapy for breast cancer Receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study Hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) AND/OR Vaginal symptoms, including dyspareunia, vaginal dryness, irritation, or thinning due to estrogen deficiency If uterus present, no prior histologically confirmed adenomatous or atypical endometrial hyperplasia or endometrial carcinoma AND no concurrent endometrial cancer confirmed by pelvic exam within the past year No active endometriosis No unexplained vaginal bleeding Hormone receptor status: Estrogen and progesterone receptor status known for patients with invasive breast cancer PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Postmenopausal No menstrual period for more than 12 months OR prior bilateral oophorectomy Must be over 55 years of age OR have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior superficial or deep venous or arterial thrombosis No serious venous stasis disease Pulmonary: No pulmonary embolus Other: Must be able to read and speak English No lower extremity trauma, swelling, or tenderness within the past 4 weeks No active gallbladder disease No migraine headaches No other prior malignancy unless curatively treated with no evidence of recurrence No concurrent seizure disorder requiring anti-seizure medication PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics No other concurrent estrogen or hormone replacement therapy No concurrent clonidine, bellergal, progestational agent, or methyldopa for hot flashes No concurrent topical vaginal estrogen cream (e.g., Estring or Vagifem) for patients with vaginal symptoms only Radiotherapy: Not specified Surgery: At least 4 weeks since prior surgery Other: At least 12 months since prior treatment for congestive heart failure Concurrent selective serotonin reuptake inhibitors (SSRI) or antidepressants with SSRI activity allowed if begun at least 3 months prior to study and continue during study

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Veterans Affairs Medical Center - Lakeside Chicago
  • CCOP - Central Illinois
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
  • CCOP - Wichita
  • CCOP - Ann Arbor Regional
  • CCOP - Kalamazoo
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • CCOP - Northern New Jersey
  • Albert Einstein Comprehensive Cancer Center
  • CCOP - Merit Care Hospital
  • Ireland Cancer Center
  • University of Pennsylvania Cancer Center
  • Fox Chase Cancer Center
  • CCOP - MainLine Health
  • CCOP - Sioux Community Cancer Consortium
  • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
  • Vanderbilt-Ingram Cancer Center
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 9, 2001
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00026286
Brief Title
Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer
Official Title
A Phase III Prospective, Randomized, Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2000 (Actual)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
June 15, 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.
Detailed Description
OBJECTIVES: Determine the efficacy of hormone replacement therapy in managing hot flashes and menopausal vaginal symptoms in postmenopausal women with a history of node-negative invasive carcinoma or ductal carcinoma in situ of the breast who are receiving adjuvant tamoxifen. Determine the effect of this regimen on blood coagulation and lipid profiles in these patients. Determine the quality of life of patients treated with this regimen. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior hysterectomy (yes vs no), symptom complex (vasomotor vs vaginal vs both), duration of hot flashes (less than 1 year or no hot flashes vs 1 year or more), and average daily number of hot flashes (less than 10 or none vs 10 or more). Patients are randomized to one of two treatment arms. Arm I: Patients who have not undergone prior hysterectomy receive oral medroxyprogesterone once daily for 6 months. If, after 1 month, symptoms do not resolve, patients receive oral conjugated estrogens once daily in addition to medroxyprogesterone for 5 months. Patients who have undergone prior hysterectomy receive oral conjugated estrogens once daily for 6 months. Arm II: Patients receive oral placebo once daily for 6 months. Quality of life is assessed at baseline and months 1, 2, 3, and 6. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes, Menopausal Symptoms
Keywords
stage I breast cancer, stage II breast cancer, breast cancer in situ, ductal breast carcinoma, hot flashes, menopausal symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
conjugated estrogens
Intervention Type
Drug
Intervention Name(s)
medroxyprogesterone

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed node-negative invasive carcinoma or ductal carcinoma in situ of the breast No contralateral breast cancer No recurrent or metastatic disease Completion of active non-hormonal therapy for breast cancer Receiving tamoxifen (20 mg/day) for at least 3 months prior to study and plan to continue drug while on study Hot flashes severe enough to seek medical intervention (at least 7-8 moderate to severe hot flashes per day or 60 per week at baseline) AND/OR Vaginal symptoms, including dyspareunia, vaginal dryness, irritation, or thinning due to estrogen deficiency If uterus present, no prior histologically confirmed adenomatous or atypical endometrial hyperplasia or endometrial carcinoma AND no concurrent endometrial cancer confirmed by pelvic exam within the past year No active endometriosis No unexplained vaginal bleeding Hormone receptor status: Estrogen and progesterone receptor status known for patients with invasive breast cancer PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Postmenopausal No menstrual period for more than 12 months OR prior bilateral oophorectomy Must be over 55 years of age OR have documented follicle-stimulating hormone levels in postmenopausal range if one or both ovaries remain after prior hysterectomy Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior superficial or deep venous or arterial thrombosis No serious venous stasis disease Pulmonary: No pulmonary embolus Other: Must be able to read and speak English No lower extremity trauma, swelling, or tenderness within the past 4 weeks No active gallbladder disease No migraine headaches No other prior malignancy unless curatively treated with no evidence of recurrence No concurrent seizure disorder requiring anti-seizure medication PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics No other concurrent estrogen or hormone replacement therapy No concurrent clonidine, bellergal, progestational agent, or methyldopa for hot flashes No concurrent topical vaginal estrogen cream (e.g., Estring or Vagifem) for patients with vaginal symptoms only Radiotherapy: Not specified Surgery: At least 4 weeks since prior surgery Other: At least 12 months since prior treatment for congestive heart failure Concurrent selective serotonin reuptake inhibitors (SSRI) or antidepressants with SSRI activity allowed if begun at least 3 months prior to study and continue during study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melody A. Cobleigh, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis (Roudebush)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

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