Elacestrant + Biologic Therapy for Breast Cancer

This trial aims to evaluate the safety and effectiveness of a combination of elacestrant (a hormone therapy), trastuzumab, and pertuzumab (both biologic therapies) for treating women with triple-positive breast cancer. Triple-positive indicates that the cancer cells grow in response to estrogen and progesterone and have more HER2 proteins than normal cells. The trial investigates how these treatments perform in patients with or without a specific gene mutation called ESR1. Women with triple-positive breast cancer, whose condition has worsened after other treatments, might be suitable candidates for this trial. As a Phase 1/Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients on certain prohibited medications cannot participate, so it's best to discuss your current medications with the trial team.

Research has shown that combining elacestrant, pertuzumab, and trastuzumab may help treat certain types of breast cancer. Earlier studies have indicated that using pertuzumab and trastuzumab together is generally safe for patients. Common side effects include diarrhea, hair loss, and tiredness, but these are usually manageable.

Elacestrant, another part of this treatment, has been tested with other drugs. Results suggest it may be safe for patients with hormone receptor-positive breast cancer. While side effects can occur, they are usually not serious.

Researchers are excited about the combination of Elacestrant with biologic therapies like Pertuzumab and Trastuzumab for breast cancer treatment because it offers a unique approach by targeting estrogen receptor pathways. Unlike traditional treatments that primarily focus on chemotherapy or hormone therapy alone, Elacestrant is a selective estrogen receptor degrader (SERD), which means it directly degrades the estrogen receptor, potentially stopping cancer growth more effectively. This combination strategy aims to enhance the effectiveness of Pertuzumab and Trastuzumab, which are well-known for targeting HER2-positive breast cancers, by also tackling the hormone receptor aspect of the cancer. By addressing multiple pathways simultaneously, this approach could offer a more comprehensive attack on cancer cells, leading to better outcomes for patients.

This trial will evaluate the combination of Elacestrant with Trastuzumab and Pertuzumab for breast cancer. Studies have shown that Elacestrant benefits patients with ESR1-mutated breast cancer, helping them live longer without disease progression compared to standard treatments. One study found it reduced the risk of disease progression or death by 45%. Pertuzumab, when combined with Trastuzumab, has extended the lives of patients with HER2-positive breast cancer by nearly 16 months. Trastuzumab also reduces the chance of breast cancer recurrence by about 34% and improves survival rates when used with chemotherapy. Together, these treatments have shown promising results in addressing different types of breast cancer. Participants in this trial will receive Trastuzumab, Pertuzumab, and Elacestrant until disease progression or unacceptable toxicity occurs.⁶⁷⁸⁹¹⁰