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A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

NCT03742102 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2026-04-24

Study results available
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Summary

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

Conditions

  • Triple Negative Breast Neoplasms

Interventions

DRUG

Durvalumab

Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8

DRUG

Capivasertib

Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off

DRUG

Oleclumab

Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1

DRUG

Paclitaxel

Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off

DRUG

Trastuzumab deruxtecan

Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w

DRUG

Datopotamab deruxtecan

Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w

Sponsors & Collaborators

Principal Investigators

  • Peter Schmid, MD, PhD · Barts Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2024-11-29
Completion
2027-02-26
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Poland
  • South Korea
  • Taiwan
  • United Kingdom

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 NCT03742102 on ClinicalTrials.gov