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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT03742102
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Triple Negative Breast Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
  • Capivasertib — DRUG
    Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
  • Oleclumab — DRUG
    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
  • Paclitaxel — DRUG
    Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
  • Trastuzumab deruxtecan — DRUG
    Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
  • Datopotamab deruxtecan — DRUG
    Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w

Study Details

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

Key Dates

Start date
Dec 21, 2018
Status verified
Apr 2026
Primary completion
Nov 29, 2024
Completion
Feb 26, 2027

Study Design

Enrollment
243 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    durvalumab + paclitaxel
  • Experimental: Arm 2
    durvalumab + paclitaxel + capivasertib
  • Experimental: Arm 5
    durvalumab + paclitaxel + oleclumab
  • Experimental: Arm 6
    durvalumab + trastuzumab deruxtecan
  • Experimental: Arm 7
    durvalumab + datopotamab deruxtecan
  • Experimental: Arm 8
    durvalumab + datopotomab deruxtecan (patients with PD-L1 positive status)

Primary Outcome Measure

Dose Limiting Toxicity (DLT) Events [ Time Frame: From the time of first dose until completion of the first cycle (28 days for Arms 2-5, 21 days for Arms 6-7 (no safety run-in for Arms 1 and 8)) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85715-
Research SiteColumbiaMaryland21044-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteGrand RapidsMichigan49503-
Research SiteSt LouisMissouri63110-
Research SiteDallasTexas75246-
Research SiteWilliamsburgVirginia23188-

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Research Site· Tucson, AZResearch Site· Columbia, MDResearch Site· Boston, MAResearch Site· Grand Rapids, MIResearch Site· St Louis, MOResearch Site· Dallas, TX

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