Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab +/- RAdiation Therapy in Triple Negative Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT03872505
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    IV administration of 5 treatments;every 2 weeks for 2 treatments and then every 4 weeks for 3 treatments
  • Radiation Therapy — RADIATION
    The second dose of durvalumab will be given in conjunction with an RT boost, consisting of 8 Gy in 3 fractions for a total of 24 Gy.
  • Carboplatin — DRUG
    IV administration weekly for 12 weeks
  • Paclitaxel — DRUG
    IV administration every week for 12 weeks

Study Details

This phase II randomized trial is for patients with clinical stage II-III, ER and PR \<10%, HER2-negative invasive breast carcinoma (triple negative breast cancer) for whom adjuvant RT is planned and pre-operative RT is deemed feasible by the treating radiation oncologist. Subjects will be randomized into arm A or B and treatment will last for 16 weeks. Both groups will receive Durvalumab 750mg IV Q2 weeks x 2 then a biopsy prior to durvalumab 1500mg IV Q4 weeks x 3 with paclitaxel and carboplatin IV weekly x 12. Arm B will receive radiation (24 Gy total) starting with the second durvalumab dose every other day (8Gy per fraction) for one week. Following treatment, subjects will receive SOC breast surgery and continue on to physician's choices SOC treatment during the 3 year follow up period. This study hopes to explore the impact of checkpoint blockade administration with a non- anthracycline chemotherapy regimen plus RT on post-surgery pathologic complete response (pCR) rate in the breast and axilla (ypT0/Tis ypN0) following 12 weeks of treatment and surgery.

Key Dates

Start date
Jul 31, 2022
Status verified
Aug 2021
Primary completion
Jul 31, 2022
Completion
Jul 31, 2027

Study Design

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

Arms

  • Active Comparator: Chemotherapy + Durvalumab
    Arm A: Carboplatin, Paclitaxel and Durvalumab
  • Experimental: Chemo + Durvalumab + Radiation Therapy
    Arm B: Carboplatin, Paclitaxel and Durvalumab + Radiation Therapy

Primary Outcome Measure

Pathological complete response rate in the breast and axilla [ Time Frame: 20 weeks from randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cedars Sinai Medical Center· Los Angeles, CA

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