T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Anatomic Stage IV Breast Cancer AJCC v8, HER2 Positive Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8

In brief

This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic). T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and abemaciclib may work better in treating patients with breast cancer compared to T-DM1 alone.

Key facts

Study ID

NCT04351230

Run by

Academic and Community Cancer Research United

People needed

0

Starts

2020-11-11

Expected to finish

2022-02-16

Last updated by the study team

2022-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PRE-REGISTRATION - INCLUSION CRITERIA
• Agree to undergo a core biopsy of breast cancer tissue derived from a local, regional or distant site for mandatory confirmation of ER+/ER-, progesterone receptor (PR) and HER2 status
• NOTE: If a single lesion is present, imaging must be completed after the lesion is biopsied and measurements must be taken from this image for disease evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) to be considered eligible for this trial
• NOTE: The study requires a fresh biopsy for clinical and research purposes and archival tissue does not suffice. If the patient has already undergone a biopsy at the time of disease progression prior to enrolling on the trial, an additional research biopsy will still be required
• Imaging or histologic evidence of progression of unresectable locally advanced or metastatic breast cancer
• One of the following must be true:
• Progressed/relapsed during or within 12 months of completing neo-adjuvant treatment with a regimen containing a taxane, trastuzumab and pertuzumab
• Progressed/relapsed during or within 12 months of completing adjuvant treatment with a regimen containing a taxane, trastuzumab and pertuzumab
• Progressed/relapsed during metastatic treatment with a regimen containing a taxane, trastuzumab and pertuzumab
• Progressed/relapsed > 12 months after receipt of adjuvant T-DM1
• A total of 1 or 2 prior lines of the following breast cancer therapies in any disease setting
• Chemotherapy alone
• HER2-directed therapy alone
• Chemotherapy with HER2 directed therapy
• Note: Any number of prior lines of endocrine therapy received in any disease setting
• Measurable disease as defined by RECIST criteria
• NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease. Disease that is measurable by physical examination only is not eligible
• Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1
• Left ventricular ejection fraction (LVEF) >= 50% as determined by echocardiography or multiple-gated acquisition imaging =< 21 days prior to pre-registration
• Able to swallow oral medication
• Provide written informed consent =< 28 days prior to pre-registration
• Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
• Willingness to provide mandatory tissue specimens for correlative research
• RANDOMIZATION - INCLUSION CRITERIA
• Local, histological confirmation of metastatic HER2-positive breast cancer per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines; one of the following must apply

You may not qualify if…

• PRE-REGISTRATION - EXCLUSION CRITERIA
• Any of the following prior therapies:
• Surgery =< 21 days prior to pre-registration
• Chemotherapy =< 21 days prior to pre-registration
• Radiation =< 14 days prior to pre-registration
• NOTE: Single fraction radiotherapy is allowed/exempt from this washout period
• NOTE: Must have fully recovered from the toxicities of therapy, except for alopecia or peripheral neuropathy
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• NOTE: Examples include interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy which interacts with the study drug(s)
• Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Or psychiatric illness/social situations that would limit compliance with study requirements
• Any of the following =< 14 days prior to pre-registration:
• Active bacterial infection (requiring intravenous [IV] antibiotics)
• Fungal infection,
• Detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C)
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active non-breast malignancy =< 3 years prior to pre-registrations
• EXCEPTIONS: Patients with a history of adequately treated cancers that are of very low risk of recurrence (i.e. papillary thyroid cancer treated with surgery, carcinoma in situ of the cervix, non-melanoma skin cancer) are eligible
• NOTE: If there is a history of prior malignancy, the patient must not be receiving other specific anti-neoplastic treatment
• History of any of the following conditions:

Where it is running

• Yuma Regional Medical Center — Yuma, Arizona, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Carle Cancer Center NCI Community Oncology Research Program — Urbana, Illinois, United States
• Michigan Cancer Research Consortium NCORP — Ann Arbor, Michigan, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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