Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer

Part of paid clinical trials in Multiple Locations, Texas.

Sponsor
US Oncology Research
Study ID
NCT02229149
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab — DRUG
    Treatment for all patients will consist of trastuzumab, given as a loading dose of 8 mg/kg IV on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter. Patients randomized to the chemotherapy plus trastuzumab arm (without pertuzumab) can receive trastuzumab 6 mg/kg IV every 3 weeks if they are receiving docetaxel or capecitabine on a 3-week cycle, or 4 mg/kg IV every 2 weeks if they are receiving vinorelbine, paclitaxel, or nab-paclitaxel on a 4-week cycle. The loading dose for all patients remains 8 mg/kg. For patients randomized to the chemotherapy plus trastuzumab plus pertuzumab arm, both trastuzumab and pertuzumab need to be administered every 3 weeks regardless of which chemotherapy agent they are receiving.
  • Pertuzumab — DRUG
    pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks.
  • Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine — DRUG
    physician's choice of chemotherapy: * Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR * Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR * Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR * Docetaxel 75 mg/m2 IV every 3 weeks; OR * Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off.

Study Details

This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane \[paclitaxel, docetaxel or nab paclitaxel\] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been previously treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.

Key Dates

Start date
Dec 31, 2014
Status verified
Nov 2022
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022

Study Design

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

Arms

  • Experimental: Triple Therapy
    Physician's choice of chemotherapy plus trastuzumab plus pertuzumab * trastuzumab, given as a loading dose of 8 mg/kg intravenously (IV, or through the vein) on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter, AND * physician's choice of chemotherapy: 1. Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR 2. Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR 3. Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR 4. Docetaxel 75 mg/m2 IV every 3 weeks; OR 5. Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off. * AND pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks.
  • Active Comparator: Double Therapy
    Physician's choice of chemotherapy plus trastuzumab * trastuzumab, given as a loading dose of 8 mg/kg intravenously (IV, or through the vein) on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter, AND * physician's choice of chemotherapy: 1. Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR 2. Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR 3. Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR 4. Docetaxel 75 mg/m2 IV every 3 weeks; OR 5. Capecitabine 1500 mg PO BID 14 days on and then 7 days off.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
19 SitesMultiple LocationsTexas--

Find similar trials in Multiple Locations, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
19 Sites· Multiple Locations, TX

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