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New treatment option for Breast Cancer
Official title Metastasis-directed Therapy for Oligometastases of Breast Cancer
ClinicalTrials.gov ID: NCT06135714
What this study is testing
What is Systemic therapy for 12 weeks after primary registration?
Systemic therapy for 12 weeks after primary registration is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negativeBC expressing PD-L1, and olaparib for cases harboring BRCA mutations.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Primary Registration Eligibility Criteria:
- Histologically diagnosed as invasive breast cancer. Biopsy from oligometastasis is desirable but not required.
- Histologically proven positive/negative for ER, PgR, and HER2, and classified as luminal, HER2-positive, or TN breast cancer.
- One of the following \ to \ ; \ In case of no history of breast cancer in the past, either (i) or (ii) below. (i) Unilateral noninvasive breast...
- Diagnosed with advanced breast cancer with oligometastasis by neck to pelvis enhanced CT, FDG-PET (PET/CT), and brain enhanced MRI.
You likely can't join if
- Active malignancies curatively treated with no evidence of disease for \>= 5 years prior to randomization.
- Infection with care.
- Fever up 38 degrees Celsius.
- Childbearing potential, delivery after 28 days, breastfeeding
- Mental disorders.
- Continuously take steroids or immunosuppressive drugs.
See the full eligibility criteria
- Primary Registration Eligibility Criteria:
- Histologically diagnosed as invasive breast cancer. Biopsy from oligometastasis is desirable but not required.
- Histologically proven positive/negative for ER, PgR, and HER2, and classified as luminal, HER2-positive, or TN breast cancer.
- One of the following \ to \ ; \ In case of no history of breast cancer in the past, either (i) or (ii) below. (i) Unilateral noninvasive breast cancer at registration, diagnosed as invasive breast cancer by biopsy from...
- Diagnosed with advanced breast cancer with oligometastasis by neck to pelvis enhanced CT, FDG-PET (PET/CT), and brain enhanced MRI.
- oligometastasis defined as: (i) Maximum diameter of each tumor is 3 cm or less (ii) Total number of 3 or less. (iii) In case of brain metastasis, maximum diameter is 2 cm or less and asymptomatic.
- No distant metastasis other than oligometastasis.
- Metastasis-directed therapy (radiation or surgery) is considered feasible for all oligometastases.
- In case of bone metastasis, none of the following: (i) Metastasis of three consecutive vertebral bodies (ii) Spinal metastasis extending into the spinal canal (Bilsky grade is 1b or higher) (iii) Long bone metastasis...
- Aged 18-80 years.
- ECOG performance status of 0 or 1.
- A measurable lesion is not required.
- No history of surgery, drug therapy, or radiotherapy for distant metastasis. Bisphosphonate preparations and RANKL inhibitors before registration, and surgery for the purpose of diagnosing metastasis are permitted.
- No radical surgery of the primary tumor or regional lymph nodes between diagnosis of oligometastasis to registration.
- In the case of recurrent breast cancer, disease-free interval of 12 months or more from surgery, perioperative chemotherapy, or molecular targeted therapy for initial treatment of breast cancer.
- No prior treatment of endocrine therapy, chemotherapy, molecular targeted therapy, and immunotherapy against any other malignancies within 5 years.
- Adequate organ function within 14 days prior to the first registration. (i) ANC \>= 1500 cells/mm3 (ii) Hemoglobin \>= 9.0 g/dL (iii) Platelet count \>= 100,000/ mm3 (iv) Serum bilirubin \<= 1.5 mg/dL (v) AST \<= 100...
- Ejection fraction of cardiac function is defined over 50%.
- Written informed consent. Secondary Registration Eligibility Criteria:
- Primary registration in this study, and the planned number of courses of systemic drug therapy by subtype has been performed.
- No progression or new distant metastasis by response evaluation.
- Secondary registration is within 28 days from response evaluation.
- Within 84-126 days from the primary registration.
- At least one oligometastasis remains on imaging and considered feasible to definitive local therapy.
- No metastasis-directed therapy for breast cancer after primary registration.
- ECOG performance status of 0 or 1.
- Adequate organ function within 14 days prior to the second registration. (i) ANC \>= 1500 cells/mm3 (ii) Hemoglobin \>= 9.0 g/dL (iii) Platelet count \>= 100,000/ mm3 (iv) Serum bilirubin \<= 1.5 mg/dL (v) AST \<= 100...
- Active malignancies curatively treated with no evidence of disease for \>= 5 years prior to randomization.
- Infection with care.
- Fever up 38 degrees Celsius.
- Childbearing potential, delivery after 28 days, breastfeeding
- Mental disorders.
- Continuously take steroids or immunosuppressive drugs.
- Unstable angina or history of cardiac infarction within 6months.
- Uncontrolled Hypertension.
- Uncontrolled Diabetes mellitus.
- Congestive heart failure deserved class II of New York Heart Association (NYHA), uncontrolled Dilated or Hypertrophic cardiomyopathy.
- Severe arrhythmia need to cure (except Atrial fibrillation, Paroxysmal supraventricular tachycardia)
- Interstitial pneumonia, pulmonary fibrosis, severe emphysema diagnosed chest CT scan.
- HBs Ag+
The study team makes the final eligibility decision.
Where it's taking place
- Tokyo, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tokyo, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.