Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

Sponsor
Swiss Cancer Institute
Study ID
NCT01835236
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab — DRUG
    First administration (loading dose) 8 mg/kg i.v. infusion over 90 min. \- then every 3 weeks until progression 6 mg/kg i.v. infusion over 30 to 90 min.
  • Pertuzumab — DRUG
    First administration (loading dose) 840 mg i.v. infusion over 60 min. \- then every 3 weeks until progression 420 mg i.v. infusion over 30 to 60 min.
  • Paclitaxel — DRUG
    Day 1, 8 and 15; every 4 weeks for ≥4 months 90 mg/m2 i.v. infusion
  • Vinorelbine — DRUG
    First administration: Day 1 and 8 25 mg/m2 i.v. infusion * then day 1 and 8, every 3 weeks for ≥4 months 30 mg/m2 i.v. infusion
  • T-DM1 — DRUG
    Every 3 weeks until unacceptable toxicity or progressive disease is observed 3.6 mg/kg i.v. infusion First dose: over 90 min (± 10 min.) Subsequent doses: over 30 min. (± 10 min.)

Study Details

In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.

Key Dates

Start date
Mar 3, 2013
Status verified
Mar 2021
Primary completion
Jan 11, 2018
Completion
May 26, 2020

Study Design

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

Arms

  • Active Comparator: Trastuzumab, Pertuzumab, T-DM1
    First line therapy: Trastuzumab, Pertuzumab Second line therapy: T-DM1
  • Active Comparator: Trastuzumab, Pertuzumab, Paclitaxel or Vinorelbine plus T-DM1
    First line therapy: Trastuzumab, Pertuzumab, Paclitaxel or Vinorelbine Second line therapy: T-DM1

Primary Outcome Measure

Overall survival (OS) - Analysis Population: ITT Population 1 [ Time Frame: 24 months ]

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