Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Scandinavian Breast Group
International Breast Cancer Study Group
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003771
First received: November 1, 1999
Last updated: September 19, 2013
Last verified: July 2001
  Purpose

RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer.

PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.


Condition Intervention Phase
Breast Cancer
Menopausal Symptoms
Biological: therapeutic estradiol
Drug: norethindrone acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Protocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy (HRT) After Previous Radical Breast Cancer Treatment

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1300
Study Start Date: September 1997
Study Completion Date: February 2004
Detailed Description:

OBJECTIVES:

  • Evaluate the safety of hormone replacement therapy, in terms of risk of recurrence, in women with previously treated, nonrecurrent stage 0-II breast cancer.
  • Compare this regimen vs non-hormonal symptomatic treatment, in terms of quality of life and risk of death, in this patient population.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified by center, prior hormone replacement therapy before diagnosis, and concurrent tamoxifen therapy. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive one of the following: Women with an intact uterus whose last menstrual bleeding has occurred within 2 years receive continuous oral cyclic estradiol-norethindrone combination comprising estradiol only on days 1-12, estradiol plus norethindrone on days 13-22, and then estradiol only on days 22-28. Women with an intact uterus whose last menstrual bleeding occurred more than 2 years prior to study receive continuous daily oral estradiol-norethindrone combination. Women who have had a hysterectomy receive continuous daily oral estradiol only.
  • Arm II: Patients receive one or more non-hormonal therapies (e.g., clonidine, beta blockers, psychological support, physical exercise, acupuncture).

Treatment in both arms continues for 2 years in the absence of disease progression. Patients may continue their randomized treatment regimen at the discretion of the treating physician.

Quality of life is assessed 3 times during the study and then every two years thereafter. Gynecological health is assessed at 3 months, 6 months, and one year during the study and then annually for at least 5 years. Breast cancer is assessed every 6 months for 3 years and then annually thereafter or at the discretion of the treating physician.

PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study within 5-6 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • History of stage 0-II breast cancer with no more than 4 involved axillary nodes if nodal status and number of nodes investigated is known
  • No current evidence of disease
  • Hormone receptor status:

    • Positive, negative, or unknown

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Menopausal or perimenopausal

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No active liver disease

Renal:

  • Not specified

Cardiovascular:

  • No prior or concurrent deep vein thrombosis
  • No hereditary traits for deep vein thrombosis
  • No prior or concurrent cerebral stroke
  • No prior or concurrent coronary disease

Other:

  • No prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No porphyria
  • No other serious disease that would prevent compliance or greatly limit life expectancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No concurrent chemotherapy

Endocrine therapy:

  • Prior hormone replacement therapy (HRT) allowed if stopped no more than 4 weeks after breast cancer diagnosis and at least 3 months prior to study
  • No prior HRT initiated after breast cancer diagnosis
  • No concurrent hormonal therapy for breast cancer except tamoxifen or toremifene

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No prior randomization into trials comparing effects of chemotherapy and bilateral oophorectomy in premenopausal women
  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: NCT00003771

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, FIN-00029
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
Sweden
Karolinska Hospital
Stockholm, Sweden, S-171 76
Uppsala University Hospital
Uppsala, Sweden, S-75185
Switzerland
Breast Center
Zurich, Switzerland, CH-8008
Sponsors and Collaborators
Regional Oncologic Center
Scandinavian Breast Group
International Breast Cancer Study Group
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Lars Holmberg, MD, PhD Uppsala University Hospital
Study Chair: Jonas Bergh, MD, PhD Karolinska Institutet
Study Chair: C. Rageth, MD, PD Breast Center
Study Chair: Janusz Jaskiewicz, MD Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003771     History of Changes
Other Study ID Numbers: CDR0000066897, ROC-HABITS, EORTC-10992, IBCSG-17-98, SBG-HABITS, EU-98077
Study First Received: November 1, 1999
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
menopausal symptoms
stage I breast cancer
stage II breast cancer
breast cancer in situ

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Norethindrone acetate
Norethindrone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on October 01, 2014