Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Overview

About this study

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria: -Patients must be ≥18 years of age -Pathologically documented breast cancer that: 1. is advanced or metastatic 2. has a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested) 3. has HER2-low or HER2 IHC >0 <1+ expression 4. was never previously HER2-positive 5. is documented HR+ disease in the metastatic setting. -No prior chemotherapy for advanced or metastatic breast cancer. -Has adequate tumor samples for assessment of HER2 status -Either disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting or disease progression within 24 months of starting adjuvant endocrine therapy and on at least 1 previous line of endocrine therapy in the metastatic setting -Has protocol-defined adequate organ and bone marrow function Key Exclusion Criteria: -Ineligible for all options in the investigator's choice chemotherapy arm -Lung-specific intercurrent clinically significant illnesses -Uncontrolled or significant cardiovascular disease or infection -Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening -Patients with spinal cord compression or clinically active central nervous system metastases -Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Brenda Ernst, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Karthik Giridhar, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20511487

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