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Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant

NCT03447132 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2023-03-10

No results posted yet for this study

Summary

This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the combination of Fulvestrant® plus Palbociclib as neoadjuvant therapy of hormone-sensitive patients with operable luminal breast cancer.

Eligible patients will be assessed upfront using the OncotypeDX® molecular test (Recurrence Score \<31).

Conditions

  • Breast Neoplasm Female

Interventions

DRUG

Fulvestrant 500mg

All patients in all arms will receive Fulvestrant 500mg

DRUG

Palbociclib 125mg

Dose reduction to 100 mg and 75 mg

DRUG

Goserelin 3.6 MG

Only for pre or peri menopausal patient

DRUG

Placebos

Placebo

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Genomic Health®, Inc.

    collaborator INDUSTRY

  • International Cancer Research Group, United Arab Emirates

    lead OTHER

Principal Investigators

  • Jean-Marc Nabholtz, MD · International Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2021-04-12
Completion
2021-07-20
FDA Drug
Yes

Countries

  • Algeria
  • Egypt
  • Jordan
  • Lebanon
  • Morocco
  • Saudi Arabia
  • Tunisia
  • United Arab Emirates

Study Locations

More Related Trials

Entities

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 NCT03447132 on ClinicalTrials.gov