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

NCT00003771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2013-09-20

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

therapeutic estradiol

DRUG

norethindrone acetate

Sponsors & Collaborators

  • Scandinavian Breast Group

    collaborator OTHER
  • ETOP IBCSG Partners Foundation

    collaborator NETWORK
  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK
  • Regional Oncologic Center

    lead OTHER

Principal Investigators

  • Lars Holmberg, MD, PhD · Uppsala University Hospital

  • Jonas Bergh, MD, PhD · Karolinska Institutet

  • C. Rageth, MD, PD · Breast Center

  • Janusz Jaskiewicz, MD · Maria Sklodowska-Curie National Research Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-09-30
Completion
2004-02-29

Countries

  • Finland
  • Norway
  • Poland
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003771 on ClinicalTrials.gov