New studies aim to improve survival for patients with HER2+ breast cancer

Roughly 20 percent of breast cancers test positive for HER2, a protein known to promote cancer growth. HER2-positive (HER2+) tumors can spread more quickly and are less sensitive to hormone therapy than other types of breast cancer. Therapies that target the HER2 protein can be effective, particularly in early-stage disease, yet effective treatments for advanced and metastatic HER2+ breast cancer are needed.

Providence Cancer Institute medical oncologists Alison Conlin, M.D., and David Page, M.D., oversee a vast portfolio of clinical trials, including two new studies for HER2+ breast cancer:

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer – PI: Dr. Alison Conlin

This study known as HER2CLIMB-02 evaluates the effectiveness of tucatinib, an experimental HER2 inhibitor, given with T-DM1, an antibody-drug conjugate approved to treat HER2+ breast cancer, compared to T-DM1 with placebo in patients with unresectable locally-advanced or metastatic HER2+ disease. Progression-free survival is the primary outcome measurement, and investigators will also evaluate overall response, duration of response and other clinical criteria.

The phase III, double-blind, randomized study is based on a phase IB trial of tucatinib and T-DM1 which showed promising early results from nine participating centers across the United States and Canada, including Providence Cancer Institute.

For more information or to enroll a patient, call our Clinical Research office at 503-215-2614 or submit a referral form.

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP) – PI: Dr. David Page

This phase II, open-label, randomized study evaluates the safety and effectiveness of standard care HER2-targeted therapy in the neoadjuvant setting with and without pembrolizumab, an immune checkpoint inhibitor approved to treat several cancers. Chemotherapy-naïve patients with invasive HER2+ breast cancer will be randomized to one of three treatment arms:

• Arm A: Trastuzumab, paclitaxel and pertuzumab
• Arm B: Trastuzumab, paclitaxel, pertuzumab and pembrolizumab
• Arm C: Trastuzumab, paclitaxel and pembrolizumab

The study, known as neoHIP, is supported by preclinical models demonstrating synergy between HER2-targeted therapy and checkpoint blockade. By administering the therapeutic combinations with curative intent in the neoadjuvant setting, investigators hope to improve survival rates for patients with HER2+ breast cancer.

For more information or to enroll a patient, call our Clinical Research office at 503-215-2614 or submit a referral form.

See more breast cancer studies

Nearly 20 research studies investigating a broad spectrum of breast cancer therapies and interventions are currently open at Providence Cancer Institute. We offer studies aimed at improving cure rates, quality of life and survival for both early-stage and metastatic breast cancer patients. These studies range from our own investigator-initiated research studies to large international studies, including studies from the National Cancer Institute and from pharmaceutical industry partners.

New studies are added frequently. Please visit our website to see all breast cancer studies currently open at Providence Cancer Institute.

A team of breast cancer specialists

The research team at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute at the Robert W. Franz Cancer Center, includes oncologists who specialize exclusively in breast cancer, as well as breast-cancer-focused research nurses, laboratory scientists, data coordinators and lab assistants. Every person on the team is passionate about providing the best possible care and the best available study options for patients with breast cancer.