Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

Summary

Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:

* Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
* Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.

Treatment in either arm will be given for eight cycles.

In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.

Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

Conditions

• HER2-negative Breast Cancer
• Triple Negative Breast Cancer

Interventions

DRUG

Capecitabine

2000 mg/m² day 1-14 q21 day cycle for eight cycles

DRUG

Carboplatin

AUC 5 q3w or AUC 1.5 weekly for eight 3 weekly cycles

DRUG

Cisplatin

25mg/m3 weekly or 75 mg/m3 q3w

DRUG

Sacituzumab govitecan

10 mg/kg body weight on days 1, 8 q3w

Sponsors & Collaborators

• Gilead Sciences

  collaborator INDUSTRY

• Austrian Breast & Colorectal Cancer Study Group

  collaborator NETWORK

• Spanish Breast Cancer Research Group (GEICAM)

  collaborator UNKNOWN

• ETOP IBCSG Partners Foundation

  collaborator NETWORK

• Cancer Trials Ireland

  collaborator NETWORK

• UNICANCER

  collaborator OTHER

• GBG Forschungs GmbH

  lead OTHER

Principal Investigators

• Frederik Marmé, MD, Prof. · ASCO, ESMO, GBG, AGO, DKG, DGS, DKG

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-28

Primary Completion

2027-03-30

Completion

2029-03-30

Countries

• Austria
• Belgium
• France
• Germany
• Ireland
• Spain
• Switzerland

Study Locations