The SAPPHO Study: Testing a New Treatment Plan for HER2+ Metastatic Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT06439693

Provider View

This study is exploring a new sequence of treatments for HER2+ metastatic breast cancer to see if starting with an intense therapy and then stopping is safe and effective. The treatment involves several drugs, including Paclitaxel, Trastuzumab, and others.

Patient Parameters

Program Overview

The study aims to test the safety and effectiveness of a series of drugs for HER2+ metastatic breast cancer. The treatment plan includes a sequence of drugs: a Taxane with Trastuzumab and Pertuzumab, followed by Trastuzumab Deruxtecan, then Tucatinib with Ado-Trastuzumab Emtansine (T-DM1), and finally Trastuzumab with Pertuzumab and Tucatinib. The goal is to see if starting with a strong treatment and then stopping is beneficial for patients. The study involves various procedures like blood tests, scans, and questionnaires, and will last about 93 weeks for treatment, with follow-up lasting up to ten years. Around 72 people will participate, and Seagen Inc. is providing support.

Description

This study is testing a new treatment plan for people with HER2+ metastatic breast cancer. The plan involves using a series of drugs that target the HER2 protein, which is involved in the growth of some breast cancers. The drugs used in this study are already approved by the FDA for treating this type of cancer. The study will give these treatments in a specific order without waiting for the cancer to worsen before stopping the treatment. Participants will undergo various tests and procedures, including blood tests, tumor biopsies, and imaging scans, to monitor their health and the effectiveness of the treatment. The study will last about 93 weeks for the treatment phase, with follow-up lasting from three months to ten years. Seagen Inc. is supporting the study by providing the drug tucatinib and funding.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced or metastatic HER2+ breast cancer that cannot be surgically removed.
  • Cancer must be stage IV at diagnosis with clear evidence of spread on imaging.
  • Must have HER2-positive cancer confirmed by specific lab tests.
  • No previous systemic therapy for invasive breast cancer, except for a specific first-line treatment within six weeks of starting.
  • Must be 18 years or older.
  • Must have a good performance status and heart function.
  • Must meet specific blood and organ function criteria.
  • HIV-positive participants are eligible if they meet certain health criteria.
  • Participants with Hepatitis B or C are eligible if they meet liver function criteria and are on appropriate treatment.
  • Participants with brain metastases are eligible if they have been treated and are stable.
  • Participants with other cancers that do not interfere with the study are eligible.
  • Must agree to use effective contraception during the study and for a specified time after.
  • Women of childbearing potential must have a negative pregnancy test before starting.
  • Must be able to understand and sign a consent form and comply with study requirements.

Exclusion Criteria

  • Previous history of invasive breast cancer.
  • Treatment with other investigational agents for this condition.
  • Recent major surgery or significant injury.
  • Recent palliative radiotherapy outside the brain.
  • Allergic reactions to similar drugs used in the study.
  • Recent heart attack or heart failure.
  • Untreated brain lesions unless approved by the study investigator.
  • Ongoing use of high-dose steroids for brain metastases.
  • Known or suspected leptomeningeal disease.
  • Uncontrolled seizures.
  • Certain heart rhythm disorders.
  • History of lung diseases requiring steroids or current lung issues.
  • Active or serious infections.
  • Difficulty swallowing pills or significant digestive issues.
  • Ongoing severe diarrhea.
  • Use of certain medications that affect drug metabolism.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts

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