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Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1

NCT02620280 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2024-03-06

No results posted yet for this study

Summary

This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and nab-paclitaxel in patients with early high-risk and locally advanced triple negative breast cancer. compared to the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in combination with carboplatin and abraxane, while the other half will receive only carboplatin and abraxane.

Conditions

  • Invasive Ductal Breast Carcinoma

Interventions

DRUG

Carboplatin

Carboplatin AUC 2 will be given i.v. on day 1 and day 8 q 3 weeks for a total of 8 cycles

DRUG

Abraxane

Abraxane, 125 mg/m2 will be given i.v. on day 1 and day 8 q 3 weeks for a total of 8 cycles

DRUG

MPDL3280A

MPDL3280A, 1200 mg. will be given i.v. infusion on day 1 q 3 weeks for a total of 8 cycles

PROCEDURE

Surgery

Breast cancer surgery (breast and axilla) either conservative or radical not later than 6 weeks

DRUG

Anthra

AC or EC (adriamycin or epirubicin and cyclophosphamide) or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles to be delivered after surgery

Sponsors & Collaborators

  • Fondazione Michelangelo

    lead OTHER

Principal Investigators

  • Luca Gianni, MD · Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2024-01-31
Completion
2024-01-07

Countries

  • Austria
  • Germany
  • Ireland
  • Italy
  • Russia
  • Spain
  • Taiwan

Study Locations

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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 NCT02620280 on ClinicalTrials.gov