Metastasis-Directed Therapy for Oligometastatic Breast Cancer

Metastasis-directed Therapy for Oligometastases of Breast Cancer

Recruiting Phase 3 Interventional Study
Breast Cancer Oligometastasis Metastatic Breast Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
340 (estimated)
Sponsor
Tokyo Medical and Dental University · Other
Who this trial is looking for

This trial is looking for women with specific types of breast cancer that have spread to a few other places in the body. Participating will involve a 12-week treatment followed by possible additional therapy if there is no disease progression.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with breast cancer.
  • I have oligometastasis with a maximum tumor size of 3 cm.
  • I am between 18 and 80 years old.
  • I have a performance status of 0 or 1.
  • I have adequate organ function.
  • I have not received any treatment for distant metastasis.
  • I have not had radical surgery for my breast cancer recently.
  • I am willing to provide written informed consent.

You may not be able to join if

  • I have an active malignancy treated less than 5 years ago.
  • I have a fever above 38 degrees Celsius.
  • I am pregnant or breastfeeding.
  • I have unstable angina or had a heart attack in the last 6 months.
  • I have uncontrolled hypertension.
  • I have uncontrolled diabetes mellitus.
  • I have severe heart problems.
  • I have interstitial pneumonia or other severe lung disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial
OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuz…
Trial Locations
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Eligibility Criteria
Primary Registration Eligibility Criteria: 1. Histologically diagnosed as invasive breast cancer. Biopsy from oligometastasis is desirable but not required. 2. Histologically proven positive/negative for ER, PgR, and HER2, and classified as luminal, HER2-positive, or TN breast cancer. 3. One of the…
Contacts

Tohiyuki Ishiba, M.D.Ph.D.

+81-3-5803-2101

ishsrg2@tmd.ac.jp

CONTACT

Ikuno Nishibuchi, M.D.Ph.D.

CONTACT