Trial ID:NCT01969643
Protocol #:14-306
Condition(s):HER2 Mutations Breast Neoplasms, HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms
Phase:I
Principal Investigator:Lynce, Filipa
Site Research Nurse(s):Campbell, Margaret,
Caradonna, Lisa,
Casella, Allison,
Germon, Victoria,
Huff, Kimberly,
Kasparian, Elizabeth,
LaPointe, Janet,
Lehnus, Jaclyn,
Macauley, Colleen,
Marchetti, Kelly,
Morse, Linda, K.
O'Driscoll, Mary,
O'Neil, Kelly,
Roche, Kathleen, A.
Rutter, Morgan,
St Amand, Myra, W.
Tiani, Elizabeth,
Trial Description:
This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients
with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.
Eligibility Requirements:
- Pathologically confirmed diagnosis of breast cancer with radiographic evidence of
incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
- One of the following:
- Part A: Triple-negative disease (ER/PR/HER2-negative) and received at least 2
prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or
ER-positive and/or PR-positive/HER2-negative disease and received at least 2
prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are
no longer a candidate for hormonal therapy (not enrolling new patients);
- Part B: Combination Arm: HER2-positive disease and received at least 2 prior
cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling
new patients);
- Part C: Triple-negative disease and received 2-4 prior non-hormonally-directed
therapies in the MBC setting (not enrolling new patients);
- Part D and Part E (dose-expansion cohort): Triple-negative disease and received 1
prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
- Part E: HR+(ER-positive and/or PR-positive)/HER2-negative disease who are
chemotherapy-eligible and not considered a candidate for further hormonal
therapy. Must have received no more than 1 prior non-hormonally-directed or
cytotoxic therapy in the LA/MBC setting.
- Part F: All of the following:
- Triple negative breast cancer
- No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic
stage disease
- Tumor tissue PD-L1 expression CPS <10 expression
- Parts A, B, C, and D: Newly obtained or archived tumor tissue biopsy, must be
collected for central pathology determination of LIV-1 expression
- Parts E and F: Archival or fresh baseline tumor sample is required.
- Measurable disease
- Eastern Cooperative Oncology Group performance status 0 or 1
- Combination Arm: adequate heart function
Exclusion Criteria:
- Pre-existing neuropathy Grade 2 or higher
- Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying
malignancy and has not been definitively treated. Parts E and F: Known or suspected
cerebral/meningeal metastasis that has not been definitively treated.
- Prior treatment with LV or prior treatment with an MMAE-containing therapy
- Combination Arm: hypersensitivity to trastuzumab
Protocol #: 14-306