Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.
Interventions
DRUGNab-paclitaxel
125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.
DRUGCarboplatin
AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles
DRUGHerceptin
In case of HER2-positive, patients receive Herceptin weekly during all cycles.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures. 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
1. Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (ypT0/is ypN0) rate | 16 weeks (at the time of definitive surgery) | Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasive disease-free survival (IDFS) | 5 years | IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer) |
| Distant disease-free survival (DDFS) | 5 years | DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer) |
| Objective response rate (ORR) | 16 weeks (at the time of definitive surgery) | ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1 |
| Breast conservation rate | 16 weeks (at the time of definitive surgery) | To determine the breast conservation rate after neoadjuvant treatment. |
| Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped | during treatment (16 weeks) | Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped. |
Countries
China
Contacts
Primary ContactJiayi Wu, Dr.
Outcome results
None listed