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

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ClinicalTrials.gov Identifier: NCT00026286
Recruitment Status : Completed
First Posted : September 17, 2003
Last Update Posted : January 2, 2019
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Hot Flashes Menopausal Symptoms Drug: conjugated estrogens Drug: medroxyprogesterone Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 2000
Actual Primary Completion Date : August 2002
Actual Study Completion Date : June 15, 2007

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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 flashes
  • 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 study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026286

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Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Melody A. Cobleigh, MD Rush University Medical Center
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ClinicalTrials.gov Identifier: NCT00026286    
Other Study ID Numbers: CDR0000069015
First Posted: September 17, 2003    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018
Keywords provided by Eastern Cooperative Oncology Group:
stage I breast cancer
stage II breast cancer
breast cancer in situ
ductal breast carcinoma
hot flashes
menopausal symptoms
Additional relevant MeSH terms:
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Breast Neoplasms
Hot Flashes
Neoplasms by Site
Breast Diseases
Skin Diseases
Medroxyprogesterone Acetate
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents