Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer

Sponsor
Renske Altena
Study ID
NCT03894007
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Docetaxel — DRUG
    75 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 4 courses preoperatively.
  • Carboplatin — DRUG
    AUC 6 iv, day 1 every third week, 4 courses preoperatively.
  • Trastuzumab — DRUG
    600 mg sc, day 1 every third week, 4 courses preoperatively. 14 courses postoperatively if complete response.
  • Pertuzumab — DRUG
    840 mg iv starting dose, thereafter 420 mg, day 1 every third week. 14 courses postoperatively if complete response in patients with baseline high risk tumours.
  • Epirubicin — DRUG
    90 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 3 courses preoperatively
  • Cyclophosphamide — DRUG
    600 mg/m2 iv, day 1 every third week, 3 courses preoperatively
  • Atezolizumab — DRUG
    840 mg iv, day 1 every third week, 3 courses preoperatively if randomised to arm A.
  • Trastuzumab emtansine — DRUG
    3.6 mg/kg iv, day 1 every third week, 14 courses postoperatively if not complete response.
  • Paclitaxel — DRUG
    80 mg/m2 iv, day 1 weekly, 12 weeks (4 cycles), in case of (anticipated) unmanageable toxicity related to docetaxel.

Study Details

This is a phase 2 study evaluating medical treatment before surgery in HER2-amplified early breast cancer patients. Patients receive chemotherapy with HER2-targeted antibodies and are randomised to receive the checkpoint inhibitor atezolizumab or not.

Key Dates

Start date
May 23, 2019
Status verified
Sep 2021
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021

Study Design

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

Arms

  • Experimental: A: Experimental
    Four courses of docetaxel or paclitaxel + carboplatin + trastuzumab sc + pertuzumab given every third week followed by three courses of epirubicin + cyclophosphamide + atezolizumab. In total seven courses of preoperative treatment. Response evaluations after course four. Postoperatively, if pathologic complete response, patients receive 14 courses of adjuvant trastuzumab every third week. If no pCR patients receive 14 courses of T-DM1 every third week.
  • Active Comparator: B: Standard
    Four courses of docetaxel or paclitaxel + carboplatin + trastuzumab sc + pertuzumab given every third week followed by three courses of epirubicin + cyclophosphamide. In total seven courses of preoperative treatment. Response evaluations after course four. Postoperatively, if pathologic complete response patients receive 14 courses of adjuvant trastuzumab (combined with pertuzumab in case of high-risk disease features) every third week. If no pCR patients receive 14 courses of T-DM1 every third week.

Primary Outcome Measure

Rate of pathological objective response to primary medical treatment [ Time Frame: At surgery 2-3 weeks after the last (of 7) cycles of neo-adjuvant systemic therapy. ]

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