A Phase 2 interventional study of Trastuzumab and Pertuzumab in Breast Neoplasms and Malignant Tumor of the Breast, sponsored by US Oncology Research. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by US Oncology Research · Phase 2, Interventional, and Treatment
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.
The current preferred first-line therapy for patients with HER2-overexpressing metastatic breast cancer (MBC) is a taxane plus trastuzumab plus pertuzumab, based on results from the CLEOPATRA trial. For patients with disease that has progressed on trastuzumab and a taxane, ado-trastuzumab emtansine (T-DM1) was recently approved based on results from the EMILIA trial showing superiority in this setting compared with capecitabine plus lapatinib. However, the standard for first-line therapy may change again in the near future, when results become available from the MARIANNE trial, which is evaluating T-DM1 alone or in combination with pertuzumab as upfront therapy. Two important questions that may be raised by the findings of this study are whether pertuzumab is effective as second- or later-line therapy following single-agent T-DM1, and whether pertuzumab administered beyond progression on prior pertuzumab therapy is of clinical benefit as trastuzumab has been proven to be.
The study will seek to determine the efficacy 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 MBC that has been previously treated with T-DM1 in the metastatic setting.
We hypothesize that the addition of pertuzumab to trastuzumab plus chemotherapy will improve median progression-free survival (PFS), compared to trastuzumab plus chemotherapy alone, as second- or later-line therapy in patients who have received prior T-DM1. Patients will be stratified according to whether they have received prior pertuzumab versus not. We will also explore whether continuing treatment with pertuzumab in patients who have been previously treated with pertuzumab improves PFS.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 33 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Previous treatment with ado-trastuzumab emtansine (T-DM1) for metastatic disease
a. Prior therapy with pertuzumab is allowed but not required
Adequate bone marrow function as indicated by the following:
Exclusion Criteria:
Patients will be excluded from the study based on the following criteria:
Uncontrolled central nervous system metastases, defined as clinical or radiologic evidence of progression of brain metastases or clinical signs of leptomeningeal disease
a. Patients with treated brain metastases are eligible provided they do not have clinical or radiologic evidence of disease progression and have been off of dexamethasone for at least 3 weeks
Requirement for chronic steroid therapy with a requirement for > 5mg/day of prednisone or the equivalent.
a. Treatment with physiologic doses of hydrocortisone up to 20 mg daily (QD) is allowed.
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.
Drug: Trastuzumab · Drug: Pertuzumab · Drug: Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine
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.
Drug: Trastuzumab · Drug: Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine
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.
Also known as: Herclon, Herceptin
pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks.
Also known as: 2C4, Perjeta, Omnitarg
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.
Also known as: Navelbine, Abraxane, Taxol, Taxotere, Docecad, Xeloda
Progression-free survival (PFS)
The primary objective of this study is to compare progression-free survival (PFS \[also known as time to disease progression\]) with the addition of pertuzumab to trastuzumab plus physician's choice of chemotherapy versus trastuzumab plus physician's choice of chemotherapy in patients who have previously received treatment with ado-trastuzumab emtansine (TDM1) for HER2+ metastatic breast cancer.
Time frame: 2 years
Progression-free survival (PFS) in patients (pts) with prior pertuzumab
To assess PFS with the addition of pertuzumab to trastuzumab plus physician's choice of chemotherapy in patients who have received prior pertuzumab;
Time frame: 2 years
Progression-free survival (PFS) in pts with prior chemotherapy
To compare median PFS with the addition of pertuzumab to trastuzumab plus physician's choice of chemotherapy in patients who have received 1 vs 2-3 prior chemotherapy regimens for metastatic disease;
Time frame: 2 years
Number of patients with complete and partial responses
To compare the objective response rates (ORR; complete response \[CR\] plus partial response \[PR\]) between the two treatment arms;
Time frame: 2 years
Overall survival
To assess overall survival (OS) in each of the treatment arms;
Time frame: 2 years
Number of adverse events and serious adverse events
To assess the safety of pertuzumab in combination with trastuzumab and physician's choice of chemotherapy (vinorelbine, paclitaxel, nab-paclitaxel, docetaxel, or capecitabine).
Time frame: 2 years
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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US Oncology Research