Status and phase
Conditions
Treatments
About
This research study is studying a combination of drugs as a possible treatment for metastatic breast cancer.
The interventions involved in this study are:
Full description
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the combination of Pembrolizumab and T-DM1 for use in patients, including people with your type of cancer.
This study will determine what amount (or dose) of Pembrolizumab and of T-DM1 is safe for people to take and what effects, good or bad, this combination may have on participants and their disease.
The FDA has not approved Pembrolizumab for this specific disease but it has been approved in the United Sates for the treatment of other types of cancer.
The FDA has approved Trastuzumab emtansine (T-DM1) as a treatment option for this type of breast cancer
The combination of Pembrolizumab and T-DM1 is investigational. It is thought that together these drugs to help get the immune system to attack tumor cells and kill cancer cells that have the HER2 protein. However, it is not known if giving the two study drugs at the same time will have a better anti-cancer effect than giving each treatment on its own.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
Either the primary tumor and/or the metastasis must have been tested for ER, PR and HER2. Patient must have HER2+ breast cancer per ASCO CAP guidelines 2013.
Prior chemotherapy:
Prior biologic therapy:
--Patients must have discontinued all biologic or investigational therapy at least 21 days before registration.
Prior radiation therapy:
In the dose de-escalation cohort: Subjects must have evaluable disease. In the expansion cohort: Subjects must have at least one lesion that is not within a previously radiated field that is measurable on computerized tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST version 1.1. Bone lesions are not considered measurable by definition.
Age is ≥18 years.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Participants must have normal organ and marrow function as defined below:
Participants enrolling in the dose expansion must have tissue that is amenable to biopsy and be willing to undergo a fresh tissue biopsy at baseline. Participants who undergo an attempted research biopsy procedure for the purpose of this protocol, and in whom inadequate tissue is obtained, are not required to undergo a repeat biopsy in order to continue on protocol.
The effects of pembrolizumab on the developing human fetus are unknown. For this reason and because tratuzumab, a component of T-DM1, is known to be teratogenic, women of child-bearing potential and men of childbearing potential must agree to use adequate contraception starting with the first dose of study therapy, for the duration of study participation, and for an additional 120 days after the last dose of study medication. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Female subject of child-bearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Patients on bisphosphonates may continue receiving bisphosphonate therapy during study treatment.
Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by echocardiogram or MUGA documented within 28 days prior to first dose of study drug.
Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal