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

The research team at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute, currently is conducting more than 120 research studies. This includes all areas of breast cancer – from early stage to late stage metastatic disease, with an average of about 20 trials at any time open for enrollment. 

Among them are several trials for patients with HER2-neu positive (HER2+) breast cancer. Roughly 20% of breast cancers test positive for HER2, a protein known to promote cancer growth. HER2+ tumors can spread more quickly, are less responsive to hormone therapy than other types of breast cancer, and can pose a higher risk for returning later as incurable breast cancer. 

Two HER2+ trials open for enrollment

Providence Cancer Institute has two new HER2+ clinical trials currently enrolling patients:

HER2CLIMB studies and effectiveness of tucatinib with T-DM1

Following the AACR/SABCS*, results of HER2CLIMB-01 – a study of the combination of tucatinib with capecitabine and trastuzumab in patients with metastatic HER2+ breast cancer after T-DM1 and other therapies – were so impressive, the FDA recently granted breakthrough status and is likely to approve the drug in the coming months.

(*American Association for Cancer Research and San Antonio Breast Cancer Symposium)

The new HER2CLIMB-02 study evaluates the effectiveness of tucatinib, a novel oral, highly selective, experimental HER2 inhibitor, given with T-DM1, an antibody drug conjugate approved to treat metastatic HER2+ breast cancer. This will be 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 this means seeing how long this combination can keep cancer controlled. The investigators will evaluate overall response, duration of response and overall survival as clinical criteria.

This 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 U.S. and Canada, including Providence Cancer Institute.

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 (Alison Conlin, M.D.)

HER-targeted therapy and pembrolizumab:

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

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab (neoHIP) 

(David Page, M.D.)


KATHERINE trial and early-stage HER2+ breast cancers

In addition to the two open trials described above, Providence Cancer Institute researchers have had a large role in the KATHERINE trial, a 10-year global pharmaceutical-run study. The results of this randomized, phase III trial, concluded that the risk of recurrence of invasive breast cancer or death was 50% lower with adjuvant T-DM1 than with trastuzumab alone. 

The KATHERINE trial focuses on higher-risk patients with residual invasive breast cancer after completion of neoadjuvant chemotherapy administered with trastuzumab-containing therapy. 

Providence was chosen as one of the sites to open the trial and participate through patient enrollment. The enrollment period is closed, and Providence and other sites are in the phase of patient monitoring and follow-up.

For more information

  • For questions or to enroll a patient, call our Clinical Research office at 503-215-2614 or submit a referral form.
  • Visit our website to see all breast cancer studies currently open at Providence Cancer Institute.
  • Providence has been a leader in immunotherapy research for more than 27 years. For a list and description of all Providence Cancer Institute clinical trials, visit


By: Alison Conlin, M.D., MPH, medical oncologist, Earle A. Chiles Research Institute, Providence Cancer Institute

About the Author

The inScope content team focuses on bringing you the latest in clinical news from our team of world-class medical providers and physician leaders.

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