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Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

NCT02668666 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-01-20

Study results available
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Summary

This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease.

Conditions

  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Estrogen Receptor Positive Breast Cancer
  • Progesterone Receptor Positive Tumor
  • Metastatic Breast Cancer

Interventions

DRUG

Palbociclib

Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28.

DRUG

Tamoxifen

Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Big Ten Cancer Research Consortium

    collaborator OTHER

  • Oana Danciu, MD

    lead OTHER

Principal Investigators

  • Oana Danciu, M.D. · Big Ten Cancer Research Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2023-07-03
Completion
2023-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02668666 on ClinicalTrials.gov