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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Menopausal Symptoms

Keywords

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menopausal symptoms stage I breast cancer stage II breast cancer breast cancer in situ

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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therapeutic estradiol

Intervention Type BIOLOGICAL

norethindrone acetate

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Lars Holmberg, MD, PhD

Role: STUDY_CHAIR

Uppsala University Hospital

Jonas Bergh, MD, PhD

Role: STUDY_CHAIR

Karolinska Institutet

C. Rageth, MD, PD

Role: STUDY_CHAIR

Breast Center

Janusz Jaskiewicz, MD

Role: STUDY_CHAIR

Maria Sklodowska-Curie National Research Institute of Oncology

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Norwegian Radium Hospital

Oslo, , Norway

Site Status

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, , Poland

Site Status

Karolinska Hospital

Stockholm, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Breast Center

Zurich, , Switzerland

Site Status

Countries

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Finland Norway Poland Sweden Switzerland

References

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Brincat M, Muscat Baron Y, Ciantar E. Hormone replacement in women with breast cancer: the HABITS study. Endocrine. 2004 Aug;24(3):255-7. doi: 10.1385/endo:24:3:255.

Reference Type BACKGROUND

PMID: 15542894 (View on PubMed)

Holmberg L, Iversen OE, Rudenstam CM, Hammar M, Kumpulainen E, Jaskiewicz J, Jassem J, Dobaczewska D, Fjosne HE, Peralta O, Arriagada R, Holmqvist M, Maenpaa J; HABITS Study Group. Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst. 2008 Apr 2;100(7):475-82. doi: 10.1093/jnci/djn058. Epub 2008 Mar 25.

Reference Type RESULT

PMID: 18364505 (View on PubMed)

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. 2004 Feb 7;363(9407):453-5. doi: 10.1016/S0140-6736(04)15493-7.

Reference Type RESULT

PMID: 14962527 (View on PubMed)