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CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO

NCT03227328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-11-07

No results posted yet for this study

Summary

Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer:

* Arm A: concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor (palbociclib, ribociclib or abemaciclib) plus endocrine therapy (aromatase inhibitor \[AI\] or fulvestrant)
* Arm B: chemotherapy plus endocrine therapy (AI or fulvestrant, administered either concomitantly from the beginning of chemotherapy or sequentially after 4-6 months of chemotherapy) Treatments will continue until disease progression or toxicity or patient refusal.

Conditions

Interventions

DRUG

concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy

CDK4/6 inhibitor: * palbociclib * ribociclib * abemaciclib Endocrine therapy: * non-steroidal or steroidal AI * fulvestrant

DRUG

chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)

Standard Chemotherapy regimens will be classified as: * anthracycline + taxane, * taxane, * anthracycline, * capecitabine / fluoropyrimidines, * others. Endocrine therapy: * non-steroidal or steroidal AI * fulvestrant

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    lead OTHER

Principal Investigators

  • Andrea Rocca · Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Maroncelli 40, 47014 Meldola, ITALY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2022-02-01
Completion
2022-07-01

Countries

  • Italy

Study Locations

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Entities

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 NCT03227328 on ClinicalTrials.gov