Clinical trial NCT03907800: Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
Official title: Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Triple Negative Breast Cancer
HER2-positive Breast Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pathological complete response (ypT0/is ypN0) rate
timeFrame: 16 weeks (at the time of definitive surgery)
Secondary outcomes:
measure: Invasive disease-free survival (IDFS)
timeFrame: 5 years
measure: Distant disease-free survival (DDFS)
timeFrame: 5 years
measure: Objective response rate (ORR)
timeFrame: 16 weeks (at the time of definitive surgery)
measure: Breast conservation rate
timeFrame: 16 weeks (at the time of definitive surgery)
measure: Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
timeFrame: during treatment (16 weeks)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Li Zhu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: