Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab Deruxtecan — DRUG
  Intravenous administration, 5.4 mg/kg on Day 1 of each 21-day cycle until radiographic disease progression as assessed by the investigator, unacceptable toxicity, other discontinuation criteria are met, or 2 years after first dose of study drug

Study Details

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.

Key Dates

Start date

Dec 30, 2023

Status verified

Apr 2026

Primary completion

Oct 1, 2027

Completion

Oct 1, 2027

Study Design

Enrollment

250 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: HR-negative, HER2-low
  Participants with HR-negative HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
• Experimental: Cohort 2: HR-negative, HER2 IHC 0
  Participants with HR-negative HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.
• Experimental: Cohort 3: HR-positive, HER2-low
  Participants with HR-positive HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd. Participants must also have recurrent disease \<2 years from the initiation of adjuvant ET or have disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor or have disease progression within the first 12 months of CDK4/6 in the first line metastatic setting.
• Experimental: Cohort 4: HR-positive, HER2 IHC 0
  Participants with HR-positive HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.

Primary Outcome Measure

Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT) [ Time Frame: Until subsequent therapy or death, assessed up to 24 months ]

Central Contacts

• (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
  908-992-6400
  [email protected]
• (Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information
  +81-3-6225-1111 (M-F 9-5 JST)
  [email protected]

Locations (5)

Find similar trials in Miami Beach, FL

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