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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
Not Enrolling
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


- 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

- Determine the effect of this regimen on blood coagulation and lipid profiles in these

- 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


- 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



- 18 and over


- 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


- Not specified


- Not specified


- Not specified


- No prior superficial or deep venous or arterial thrombosis

- No serious venous stasis disease


- No pulmonary embolus


- 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


Biologic therapy:

- Not specified


- 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

- No concurrent topical vaginal estrogen cream (e.g., Estring or Vagifem) for patients
with vaginal symptoms only


- Not specified


- At least 4 weeks since prior surgery


- 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

Type of Study:


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


United States: Federal Government

Study ID:




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



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