Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
NCT ID: NCT03907800
Last Updated: 2022-10-27
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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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2019-04-01
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nab-paclitaxel + Carboplatin ± Herceptin
Nab-paclitaxel
125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.
Carboplatin
AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles
Herceptin
In case of HER2-positive, patients receive Herceptin weekly during all cycles.
Interventions
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Nab-paclitaxel
125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.
Carboplatin
AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles
Herceptin
In case of HER2-positive, patients receive Herceptin weekly during all cycles.
Eligibility Criteria
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Inclusion Criteria
2. Age at diagnosis ≥ 18 years, female.
3. Histologically confirmed diagnosis of HER2-opsitive or triple-negative breast cancer. ER/PR-negativity is defined as ≤1% stained cells； HER2-positivity is defined as IHC 3+ or in-situ hybridisation (ISH) ratio \>2.0.
4. cT2-4NanyM0 or cTanyN1-3M0
5. ECOG ≤ 1, LVEF ≥ 55%.
6. Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥ 1.5 × 109 / L and platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g/L; for hepatic function, total bilirubin ≤ 1.5 × UNL, AST and ALT ≤ 2.5 × UNL; for renal function, SCr ≤ 1.5 × UNL
7. Patients must be available and compliant for treatment and follow-up.
Exclusion Criteria
2. Known or suspected congestive heart failure (\> NYHA I)
3. Currently active infection or severe symptomatic visceral disease.
4. Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
5. rior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
6. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
7. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
18 Years
FEMALE
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Li Zhu
Professor
Principal Investigators
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Li Zhu, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RJBC1801
Identifier Type: -
Identifier Source: org_study_id
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