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Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

NCT03238703 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-12-27

No results posted yet for this study

Summary

This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.

Conditions

  • HER2/Neu Negative
  • Invasive Breast Carcinoma
  • Postmenopausal
  • Stage 0 Breast Cancer
  • Stage IA Breast Cancer

Interventions

DRUG

Anastrozole

Given PO

DRUG

Exemestane

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Letrozole

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Tamoxifen Citrate

Given PO

DRUG

Toremifene Citrate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Vijayakrishna Gadi · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2023-03-14
Completion
2025-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03238703 on ClinicalTrials.gov