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New treatment option for Triple Negative Breast Cancer
Official title Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients
ClinicalTrials.gov ID: NCT06225284
What this study is testing
What is Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg?
Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for triple negative 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
- Breast cancer (BC), especially premenopausal, is emerging rapidly in East Asia in recent 20 years. Half of the breast cancer patients in Asia are younger than 50 years of age.
- Phase 2: a mid-size study of how well it works
- 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 and older, women only
You may be able to join if
- Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- Written informed consent must be obtained before any assessment is performed.
- Female patients aged ≥ 18 years at screening; Must be premenopausal according to serum E2, FSH level.
- Histological confirmed TNBC, as defined by the most recent ASCO/CAP guidelines. Hormone receptor-low/HER2 negative as defined by ER 1% to \<10%...
- Have previously untreated locally advanced non-metastatic (M0) TNBC and hormone receptor-low/HER2-negative defined as the following combined primary...
You likely can't join if
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the...
- Patients have received any prior therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or hormone therapy) for breast cancer.
- Evidence of systemic metastasis.
- Pregnancy or lactation.
- Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer...
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or...
See the full eligibility criteria
- Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- Written informed consent must be obtained before any assessment is performed.
- Female patients aged ≥ 18 years at screening; Must be premenopausal according to serum E2, FSH level.
- Histological confirmed TNBC, as defined by the most recent ASCO/CAP guidelines. Hormone receptor-low/HER2 negative as defined by ER 1% to \<10% and/or PR 1% to \<10% on IHC staining; neither hormone receptor may be ≥...
- Have previously untreated locally advanced non-metastatic (M0) TNBC and hormone receptor-low/HER2-negative defined as the following combined primary tumor (T) and regional lymph node (N) staging per current AJCC staging...
- Agree to receive core needle biopsy for translational research.
- ECOG 0-1.
- Patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:
- Hemoglobin ≥ 9.0 g/dL;
- Absolute neutrophil count ≥ 1,500 /μL;
- Platelets ≥ 100,000/μL;
- Total bilirubin ≤1.5 x upper normal limit;
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit;
- Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≧50ml/min;
- aPTT \< 1.5 x upper normal limit (unless on therapeutic anti-coagulation);
- Plan to receive breast cancer surgery.
- Must have a negative pregnancy test obtained within 3 days before starting therapy. Patients must not be breastfeeding.
- Patients must use effective contraception prior to study entry and for the duration of study participation, and for 6 months after the completion of therapy.
- Patients (or a surrogate) must be able to comply with study procedures and to give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and...
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the Investigator, in order to ensure that the study population will be...
- Patients have received any prior therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or hormone therapy) for breast cancer.
- Evidence of systemic metastasis.
- Pregnancy or lactation.
- Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs, with exception of hydroxychloroquine...
- Has a diagnosis of immunodeficiency or is receiving high dose of systemic steroid therapy. Patients with minor medical disease condition (i.e. mild asthma) requiring prednisolone equal to or less than 20 mg/day or the...
- Has an active systemic bacterial, viral or fungal infection requiring systemic therapy.
- Psychiatric illness or social situation that would preclude study compliance.
- Serious non-healing wound, ulcer, or bone fracture. Except for breast cancer related non-healing wound or ulcer.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrolment.
- History of allergic reaction to compounds of similar chemical composition to the study drugs.
- Any of the following conditions or treatments that may impact the safety of the patient:
- History of, or current, significant cardiac disease including cardiac failure (NYHA functional class II-IV), myocardial infarction (within 6 months), unstable angina (within 6 months), transient ischemic attack (within...
- Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker on screening electrocardiogram (ECG)
- History of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis
- Severe hepatic impairment (Child-Pugh class C)
- Any medically unstable condition as determined by the Investigator
- Patients unable or unwilling to undergo serial breast tumor biopsy.
- History of hypersensitivity to any of the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. 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.