Phase III Randomized Study of Hormone Replacement Therapy in Menopausal or Perimenopausal Women With Prior Stage 0-II Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

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First Published: 4/1/1999     Last Modified: 8/18/2009  

Alternate Title

Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careClosedNot specifiedOtherROC-HABITS
EORTC-10992, IBCSG-17-98, SBG-HABITS, EU-98077, NCT00003771

Objectives

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

Entry 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

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

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

Expected Enrollment

1300

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

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.

Published Results

Holmberg L, Iversen OE, Rudenstam CM, et al.: Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst 100 (7): 475-82, 2008.[PUBMED Abstract]

Holmberg L, Anderson H; HABITS steering and data monitoring committees: HABITS (hormonal replacement therapy after breast cancer--is it safe?), a randomised comparison: trial stopped. Lancet 363 (9407): 453-5, 2004.[PUBMED Abstract]

Related Publications

Brincat M, Muscat Baron Y, Ciantar E: Hormone replacement in women with breast cancer: the HABITS study. Endocrine 24 (3): 255-7, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Regional Oncologic Center

Lars Holmberg, MD, PhD, Protocol chair
Ph: 46-18-151-910
Email: Lars.Holmberg@akademiska.se

Scandinavian Breast Group

Jonas Bergh, MD, PhD, Protocol chair
Ph: 46-8-517-762-79

International Breast Cancer Study Group

C. Rageth, MD, PD, Protocol chair
Ph: 41-44-380-76-60
Email: c.rageth@brust-zentrum.ch

European Organization for Research and Treatment of Cancer

Janusz Jaskiewicz, MD, Protocol chair
Ph: 48-22-644-0024

Registry Information

Official TitleProtocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy (HRT) After Previous Radical Breast Cancer Treatment
Trial Start Date1997-09-17
Registered in ClinicalTrials.govNCT00003771
Date Submitted to PDQ1999-02-05
Information Last Verified2001-07-06

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.