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.

Inclusion Criteria:

  • Patients must be ≥ 18 years of age.
  • Pathologically documented breast cancer that:
    • is advanced or metastatic;
    • 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);
    • has HER2-low or HER2 IHC >0 <1+ expression;
    • was never previously HER2-positive. 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.
  • Must have had either:
    • Disease progression on endocrine therapy + CDK4/6 inhibitor within 6 months of starting first line treatment for metastatic disease and considered appropriate for chemotherapy as the next treatment by the investigator; OR
    • Disease progression on at least 2 previous lines of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) administered for the treatmentof metastatic disease.
  • Has protocol-defined adequate organ and bone marrow function.

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.

Eligibility last updated 11/24/21. Questions regarding updates should be directed to the study team contact.

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

Jacksonville, Fla.

Mayo Clinic principal investigator

Pooja Advani, M.B.B.S., 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

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

More information

Publications

Publications are currently not available
.
CLS-20511487

Mayo Clinic Footer