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PalbocIclib in PreMenopausal Women With ER Positive/HER-2 Negative MetAstatic Breast Cancer

NCT02917005 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-07-28

No results posted yet for this study

Summary

This is an open label, randomized, multicenter, international phase II study for premenopausal patients with hormone receptor positive, HER2 negative metastatic or locally advanced breast cancer. Patients will be randomized to receive either palbociclib + exemestane + OFS (Arm 1) or exemestane +OFS (Arm 2).

Treatment will be continued until disease progression, unacceptable toxicities, or withdrawal of consent.

Conditions

Interventions

DRUG

Palbociclib

CDK 4/6 inhibitor

DRUG

Exemestane

Aromatase inhibitor

DRUG

Goserelin

LHRH agonist

Sponsors & Collaborators

  • Hamdy A. Azim

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2021-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Entities

Drugs
Diseases

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 NCT02917005 on ClinicalTrials.gov