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AMTEC IIT: Phase 2 Multiarm Study in TNBC

NCT03801369 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-25

Study results available
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Summary

This phase II study assesses the efficacy of the combination of olaparib with durvalumab, selumetinib, or capivasertib or ceralasertib alone in the treatment of patients with metastatic triple negative breast cancer (TNBC). Olaparib may stop growth of tumor cells by inhibiting some of the enzymes (ADP ribose polymerase \[PARP\]) needed for cell growth. Durvalumab, a monoclonal antibody, inhibits the growth and spread of tumors by stimulating the patient's antitumor immune response. Selumetinib, capivasertib, and ceralasertib are inhibitor drugs that may stop the growth of tumor cells by blocking some of the enzymes (MEK, AKT, ATR) needed for cell growth. Giving olaparib together with durvalumab, selumetinib, or capivasertib or giving ceralasertib alone may provide an effective method to treat patients with metastatic triple negative breast cancer.

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Triple-Negative Breast Carcinoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy

DRUG

Capivasertib

Given PO (orally)

DRUG

Ceralasertib

Given PO (orally)

BIOLOGICAL

Durvalumab

Given IV (infusion)

DRUG

Olaparib

Given PO (orally)

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Selumetinib

Given PO (orally)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Oregon Health and Science University

    collaborator OTHER

  • Gordon Mills, MD, PhD

    lead OTHER

Principal Investigators

  • Gordon Mills, MD, PhD · OHSU Knight Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2024-10-22
Completion
2024-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03801369 on ClinicalTrials.gov