Howell Township

Researchers are evaluating multiple treatment combinations in a Phase Ib/II, open-label, multicenter, randomized umbrella study for women with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+) breast cancer. The study focuses on three groups: those with HER2-negative breast cancer who progressed after treatment with cyclin-dependent kinase 4/6 inhibitors; those with HER2-positive breast cancer who progressed after standard anti-HER2 therapies; and those with HER2-negative, PIK3CA-mutated breast cancer resistant to endocrine therapy. The study is designed to allow new treatment arms to open, existing arms to close, or patient populations to change based on clinical activity or toxicity. Participants will receive various oral drugs including Giredestrant, Abemaciclib, Ipatasertib, Inavolisib, Ribociclib, Everolimus, Samuraciclib, Palbociclib, and intravenous drugs like Atezolizumab. One treatment arm includes a fixed-dose subcutaneous combination of pertuzumab and trastuzumab. Treatments are given in cycles of either 21 or 28 days and continue until unacceptable side effects or disease progression. Some arms have specific dosing schedules, such as daily oral doses or intravenous infusions on certain days of each cycle. During the study, participants will be monitored through assessments including tumor measurements using RECIST v1.1 criteria to evaluate response, and tracking of any adverse events according to standardized criteria for up to six years. Researchers will collect tumor specimens for biomarker testing and assess safety through clinical evaluations. The study measures the percentage of participants showing complete or partial tumor response and records treatment side effects from baseline until 30 days after the last dose.

Researchers are evaluating the effectiveness and safety of several treatment combinations in people with metastatic or inoperable locally advanced breast cancer. This study includes multiple groups based on breast cancer subtypes and prior treatments, such as triple-negative breast cancer (TNBC) with or without prior therapy, and hormone receptor-positive or HER2-positive cancers with specific genetic mutations. The study is designed in two stages, with participants assigned to different treatment arms in the first stage, and some eligible participants continuing to a second stage if their disease progresses or they experience side effects. The treatments studied include various drugs given alone or in combination, such as oral medications like Capecitabine and Ipatasertib, intravenous antibodies like Atezolizumab and Trastuzumab Deruxtecan, and chemotherapy agents like Gemcitabine with Carboplatin or Eribulin. Dosing schedules vary by drug and combination, with cycles typically lasting 21 or 28 days. Some drugs are administered orally daily or on specific days, while others are given by intravenous infusion or subcutaneous injection. Participants will undergo regular assessments including scans and tumor biopsies to measure disease response and monitor safety. Researchers will collect tumor samples for biomarker analysis and perform laboratory tests to check organ function. The main outcome measured is the objective response rate, tracked from baseline until disease progression or loss of clinical benefit, which could be up to about 10 years. Participants must be able to comply with study procedures and will be monitored closely throughout their participation.