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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Hot Flashes, Menopausal Symptoms

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Melody A. Cobleigh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000069015

NCT ID:

NCT00026286

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • Menopausal Symptoms
  • stage I breast cancer
  • stage II breast cancer
  • breast cancer in situ
  • ductal breast carcinoma
  • hot flashes
  • menopausal symptoms
  • Breast Neoplasms
  • Carcinoma, Intraductal, Noninfiltrating
  • Hot Flashes

Name

Location

Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212