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Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

NCT05063786 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-09-08

No results posted yet for this study

Summary

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

Conditions

Interventions

BIOLOGICAL

Trastuzumab

6 mg/kg IV every 3 weeks (3-weekly schedule), or 4 mg/kg IV loading dose, followed by 2mg/kg IV weekly (weekly schedule)\*, or 600 mg SC every 3 weeks. \* If using trastuzumab IV, a loading dose of 8 mg/kg (for the 3-weekly schedule), or 4 mg/kg (for the weekly schedule) is necessary if more than 6 weeks have passed since the previous trastuzumab dose.

DRUG

Alpelisib

300 mg oral once daily.

DRUG

Fulvestrant

500 mg intramuscular every 4 weeks plus loading dose on day 15 cycle 1.

DRUG

Vinorelbine

Oral (60 mg/m2) or IV (25 or 30 mg/m2 per investigator preference) on days 1 and 8, every 3 weeks.

DRUG

Capecitabine

1250 or 1000 mg/m2 (per investigator preference) twice a day (BID) oral, 2 weeks on, 1 week off, every 3 weeks.

DRUG

Eribulin

1.23 mg/m2 IV on days 1 and 8, every 3 weeks.

Sponsors & Collaborators

  • ETOP IBCSG Partners Foundation

    collaborator NETWORK

  • Breast International Group

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Spanish Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Study Director · H. Clínico Universitario Valencia. Valencia, Spain.

  • Study Director · Istituto Europeo di Oncologia. Milan, Italy.

  • Study Director · Princess Margaret Cancer Center. Toronto, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Austria
  • France
  • Italy
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

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 NCT05063786 on ClinicalTrials.gov