NCT00003771

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Sep 1997

Typical duration for phase_3 breast-cancer

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

September 20, 2013

Status Verified

July 1, 2001

First QC Date

November 1, 1999

Last Update Submit

September 19, 2013

Conditions

Breast CancerMenopausal Symptoms

Keywords

menopausal symptomsstage I breast cancerstage II breast cancerbreast cancer in situ

Interventions

therapeutic estradiolBIOLOGICAL
norethindrone acetateDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Karolinska Hospital

Stockholm, S-171 76, Sweden

Location

Uppsala University Hospital

Uppsala, S-75185, Sweden

Location

Breast Center

Zurich, CH-8008, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 15542894BACKGROUND

  • 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.

    PMID: 18364505RESULT

  • 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.

    PMID: 14962527RESULT

MeSH Terms

Conditions

Breast NeoplasmsBreast Carcinoma In Situ

Interventions

EstradiolNorethindrone Acetate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorethindroneNorpregnenesNorpregnanesNorsteroids

Study Officials

  • 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 National Research Institute of Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1997

Study Completion

February 1, 2004

Last Updated

September 20, 2013

Record last verified: 2001-07

Locations

NO(1)PL(1)SE(2)FI(1)CH(1)