Organoid-based Functional Precision Therapy for Advanced Breast Cancer
NCT ID: NCT06102824
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
252 participants
INTERVENTIONAL
2024-10-01
2028-06-30
Brief Summary
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Detailed Description
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This multicenter, open-label, randomized phase II trial aims to investigate the safety and efficacy of organoid-guided treatment (OGT) versus treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. Randomization will be stratified by hormone receptor status and prior chemotherapy for the advanced or metastatic disease. Subjects in the OGT group will receive treatment predicted to be the most efficacious by the PDO drug sensitivity screening, and subjects in the TPC group will receive treatment selected by the treating physician. Treatments tested in PDO drug screening or chosen by the treating physician will be guided by NCCN guidelines. Treatment that subjects have previously received before randomization is no longer subjected to PDO sensitivity screening. This study will provide valuable evidence on the real-time application of PDOs in the context of clinical care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Organoid-guided treatment
Subjects randomized to the organoid-guided treatment (OGT) group will be treated with the drugs predicted to be the most sensitive through PDO drug sensitivity screening. Drugs that the subjects have progressed on before randomization will not be screened. The drugs selected for organoid screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).
Organoid-guided treatment
The drugs predicted to be the most sensitive through organoid drug sensitivity screening. The drugs selected for sensitivity screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).
Treatment of physician's choice
Subjects randomized to the treatment of physician's choice (TPC) group will receive physician-chosen therapy from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).
Taxane
Albumin-bound paclitaxel 260mg/m2, IV, q3w, or 100-125mg/m2, IV, days 1, 8, and 15, q4w OR Liposomal paclitaxel 175mg/m2, IV, q3w
Capecitabine
1000-1250mg/m2, PO, bid, days1-14, q3w
Gemcitabine
800-1200mg/m2, IV, days 1, 8, q3w
Vinorelbine
20-35mg/m2, IV, days 1 and 8, q3w
Eribulin
1.4mg/m2, IV, days 1 and 8, q3w
Anthracycline
Liposomal doxorubicin 50mg/m2, IV, q3w OR Liposomal doxorubicin 40mg/m2+Cyclophosphamide 600mg/m2, IV, q3w
Carboplatin
Carboplatin AUC 6, IV, q3w or q4w OR Carboplatin AUC 2+Gemcitabine 1000mg/m2, IV, days 1 and 8, q3w OR Carboplatin AUC 2+Albumin-bound paclitaxel 125mg/m2, IV, days 1 and 8, q3w
Utidelone
30mg/m2, IV, once per day on days 1-5, q3w
Trastuzumab deruxtecan
5.4mg/kg, IV, q3w
Sacituzumab govitecan
10mg/kg, IV, days 1 and 8, q3w
Interventions
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Organoid-guided treatment
The drugs predicted to be the most sensitive through organoid drug sensitivity screening. The drugs selected for sensitivity screening are from the following options: taxane, anthracycline, 5-fluorouracil, gemcitabine, vinorelbine, eribulin, utidelone, carboplatin, sacituzumab govitecan, and trastuzumab deruxtecan (for HER2-low patients).
Taxane
Albumin-bound paclitaxel 260mg/m2, IV, q3w, or 100-125mg/m2, IV, days 1, 8, and 15, q4w OR Liposomal paclitaxel 175mg/m2, IV, q3w
Capecitabine
1000-1250mg/m2, PO, bid, days1-14, q3w
Gemcitabine
800-1200mg/m2, IV, days 1, 8, q3w
Vinorelbine
20-35mg/m2, IV, days 1 and 8, q3w
Eribulin
1.4mg/m2, IV, days 1 and 8, q3w
Anthracycline
Liposomal doxorubicin 50mg/m2, IV, q3w OR Liposomal doxorubicin 40mg/m2+Cyclophosphamide 600mg/m2, IV, q3w
Carboplatin
Carboplatin AUC 6, IV, q3w or q4w OR Carboplatin AUC 2+Gemcitabine 1000mg/m2, IV, days 1 and 8, q3w OR Carboplatin AUC 2+Albumin-bound paclitaxel 125mg/m2, IV, days 1 and 8, q3w
Utidelone
30mg/m2, IV, once per day on days 1-5, q3w
Trastuzumab deruxtecan
5.4mg/kg, IV, q3w
Sacituzumab govitecan
10mg/kg, IV, days 1 and 8, q3w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Men or women ≥18 years old.
3. Pathologically documented unresectable locally advanced or metastatic breast cancer that:
3.1 Confirmed as HER2-negative status, defined as IHC 0, IHC 1+, or IHC 2+/ISH- according to American Society of Clinical Oncology College of American Pathologists (ASCO/CAP) guidelines evaluated at a local laboratory.
3.2 Is HR-positive or HR-negative. Positive for estrogen receptor or progesterone receptor if a finding of ≥1% of tumor cell nuclei is immunoreactive according to ASCO/CAP guidelines.
3.3 Has been treated with at least 1 prior line of systemic therapy in the advanced or metastatic setting. If \>10% ER expression, the subject should have been treated with a CDK4/6 inhibitor. If recurrence occurred within 6 months of adjuvant chemotherapy, adjuvant therapy would count as 1 line of systemic therapy. If recurrence occurred within 12 months of adjuvant CDK4/6 inhibitor and endocrine therapy, adjuvant therapy would count as 1 line of systemic therapy.
4. Documented radiologic progression (during or after most recent treatment).
5. Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
7. All subjects must have a recent tumor sample after the most recent treatment regimen or agree to undergo a tissue biopsy prior to randomization.
8. No visceral crisis.
9. Life expectancy of ≥ 6 months as assessed by the treating investigator.
10. Complete all required baseline laboratory tests and imaging examinations within 28 days before randomization.
11. Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
12. Male and female subjects of reproductive/childbearing potential must have a documented negative pregnancy test within 2 weeks prior to randomization and agree to acceptable birth control (non-hormonal) during and up to 6 months after trial therapy.
Subjects must satisfy all of the following additional criteria to be included in the OGT group:
1. No absolute contraindication for invasive procedures to obtain samples for organoid generation.
2. Sufficient material for organoid generation: biopsied samples (length\>1cm, 2-3 pieces), surgically resected samples (\>1cm×1cm×0.5cm, weight\>200mg), malignant effusion samples collected by thoracentesis, abdominocentesis or lumbar puncture (pleural fluid\>50mL, ascites\>50mL, cerebrospinal fluid≥4 tubes with each tube ≥4mL).
3. Successful acquisition of a solid tumor biopsy sample containing ≥ 20% tumor content, or malignant effusion sample (e.g., pleural, or pericardial effusion or ascites) confirmed to contain malignant cells.
Exclusion Criteria
2. Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
3. Known active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically and radiologically stable for at least 4 weeks before first dose of trial treatment and have not required high-dose steroid treatment in the last 4 weeks).
4. Inflammatory breast cancer.
5. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
6. Major surgery within 3 weeks of starting study treatment: patients must have recovered from any effects of any major surgery.
7. Systemic treatment with anticancer therapy, antibody-based therapy, hormonal therapy, or radiotherapy within 3 weeks before study treatment.
8. Participation in a therapeutic clinical study within 3 weeks before study treatment, or current participation in other investigational procedures.
9. Has multiple primary malignancies within 3 years, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, or contralateral breast cancer.
10. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
11. Substance abuse or medical conditions such as clinically significant cardiac or pulmonary diseases or psychological conditions, that would, in the opinion of the Investigator, increase the safety risk to the subject or interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
12. Has known human immunodeficiency virus infection or active hepatitis B or C infection.
13. Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
14. Has gastrointestinal disorders likely to interfere with absorption of the study medication.
15. Is pregnant or breastfeeding or planning to become pregnant.
16. Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
18 Years
80 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Shantou Central Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Kun Wang
M.D.
Locations
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20231028
Identifier Type: -
Identifier Source: org_study_id
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