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HR+/HER2- Advanced Breast Cancer and Endocrine Resistance

NCT03322215 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-03-08

No results posted yet for this study

Summary

This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included.

The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment.

Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine.

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Palbociclib

75-125 mg capsule orally once daily for 21 consecutive Days followed by 7 Days of treatment.

DRUG

Fulvestrant

500 mg intramuscularly Days 1 and 15 of cycle 1, and then on Day 1 of each subsequent 28-days cycle.

DRUG

Capecitabine

Oral tablet 500 - 1,250 mg/m2 twice Daily, for 2 weeks followed by 1 week of rest.

Sponsors & Collaborators

  • Theodoros Foukakis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2021-04-30
Completion
2023-10-31
FDA Drug
Yes

Countries

  • Sweden
  • United Kingdom

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 NCT03322215 on ClinicalTrials.gov