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RecruitingPhase 1 / Phase 2

Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests patritumab deruxtecan (MK-1022) with other cancer drugs for HER2-positive breast cancer that has spread nearby or to other body parts and cannot be removed by surgery. HER2 is a protein that helps cancer cells grow. Researchers will check side effects and see whether treatment makes the cancer shrink or go away.

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must show HER2-positive breast cancer that has spread nearby and cannot be removed by surgery, or has spread to other body parts.
  • You must be fully active or able to do light work, as checked within 7 days before treatment starts.
  • If you have HIV, it must be well controlled with medicine. If you test positive for hepatitis B surface antigen, you must have taken hepatitis B medicine for at least 4 weeks and have no virus found in your blood before group assignment. If you have had hepatitis C, no virus can be found in your blood.
  • Part 1, Arm 1: You must have had 2 to 5 prior courses of HER2-targeted treatment for cancer that spread nearby or to other body parts. The cancer must have gotten worse during or after trastuzumab deruxtecan (T-DXd).
  • Part 1, Arm 2: You must have had no more than 5 prior courses of HER2-targeted treatment for cancer that spread nearby or to other body parts.
  • Part 1, Arm 3: The cancer must have gotten worse after T-DXd, and T-DXd must be your most recent treatment. You may have had no more than 3 prior courses of HER2-targeted treatment for cancer that spread nearby or to other body parts.
  • Part 2: You must not have had medicine that treats cancer throughout the body, including T-DXd, for breast cancer that came back and spread nearby or to other body parts.

Who can't join

  • You have serious or uncontrolled heart or blood vessel disease.
  • You have ever had lung inflammation or scarring not caused by infection, have it now, or may have it now. Severe breathing problems also rule you out.
  • You have cancer pressing on the spinal cord or cancer that has spread to the brain. Any past or current cancer in the tissues around the brain or spinal cord also rules you out. Part 2 also excludes spread elsewhere in the central nervous system.
  • You have serious disease of the cornea, the clear front part of the eye.
  • You have an uncontrolled infection affecting the body, an active infection needing medicine that works throughout the body, or active hepatitis B and C at the same time.
  • You have another cancer that is getting worse or needed treatment in the past 3 years. If you have HIV, a history of Kaposi's sarcoma or multicentric Castleman's disease also rules you out.
  • You had major surgery less than 28 days ago, except surgery to place a device for access to a blood vessel.
  • Part 1, Arm 3 only: You previously took tucatinib, lapatinib, neratinib, or an experimental HER2-targeted drug called a tyrosine kinase inhibitor for cancer that spread nearby or to other body parts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 Part 1 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 Part 1 Arm 2: -Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting Part 1 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. Part 2 : Has not received prior systemic therapy (including T-DXd) for recurrent locally advanced or metastatic breast cancer (mBC). Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Uncontrolled or significant cardiovascular disease * Has any history of (noninfectious) interstitial lung disease (ILD)/ pneumonitis irrespective of steroid use or has current ILD or suspected ILD * 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 * Part 1: Evidence of spinal cord compression or brain metastases * Part 2: Evidence of spinal cord compression or brain/CNS 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 Part1: 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

Study sites (5)

CO

MA

NJ

SC

VA