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Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

NCT02894398 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2023-03-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline therapy in combination with palbociclib (Ibrance)

Conditions

  • Breast Cancer
  • Hormone Receptor Positive Tumor
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Interventions

DRUG

Palbociclib

Capsules (commercially available, obtained from local pharmacies), 125mg daily, 21 days, 7 days off, cycles of 28 days. Dose reductions: 100mg, 75mg (no change in administration schedule) Number of cycles: until disease progression, intolerable toxicity, death or any other reasons

DRUG

Letrozole

Letrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 2.5mg/daily, oral intake

DRUG

Anastrozole

Anastrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 1mg/daily, oral intake

DRUG

Exemestane

Exemestane will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 25mg/daily, oral intake

DRUG

Fulvestrant

Fulvestrant will be administered as basic therapy (commercially available injection, obtained from local pharmacies) as followed: 500mg/once monthly, intramuscular injection

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • iOMEDICO AG

    lead INDUSTRY

Principal Investigators

  • iOMEDICO AG · Freiburg / Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-06
Primary Completion
2023-02-15
Completion
2023-02-15

Countries

  • Germany

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 NCT02894398 on ClinicalTrials.gov