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HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants with HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

HER3-DXd with Other Anticancer Agents in HER2+ Unresectable Locally Advanced BC or mBC

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@merck.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@merck.com

Recruiting

May. 23, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

The main inclusion criteria include but are not limited to the following:
- Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer.
- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention.

Arm 1:
- Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting.
- Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment.

Arm 2:
- Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting.

Arm 3:
- Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.

The main exclusion criteria include but are not limited to the following:
- Uncontrolled or significant cardiovascular disease.
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease.
- Has clinically severe respiratory compromise.
- Has any history of or evidence of any current leptomeningeal disease.
- Has clinically significant corneal disease.
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Evidence of spinal cord compression or brain metastases.
- Has an active infection requiring systemic therapy.
- Concurrent active HBV and HCV infection.
- Has had major surgical procedure (excluding placement of vascular access) less than 28 days.

Arm 3 ONLY:
- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting.

Both

Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Arm 1: HER3-DXd in combination with Trastuzumab will be administered as an intravenous (IV) infusion on Day 1 of each every 3 weeks (Q3W) cycle.
Arm 2: HER3-DXd in combination with Pertuzumab and Trastuzumab will be administered as an IV infusion on Day 1 of each Q3W cycle.
Arm 3: HER3-DXd in combination with Trastuzumab will be administered as an IV infusion on Day 1 of each Q3W cycle. Tucatinib will be administered orally twice daily.

Safety and tolerability

Pharmacokinetics

+81-52-851-5511

May. 01, 2025

Yes

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