Neoadjuvant Nab-paclitaxel in Triple-negative or HER2-positive Breast Cancer

NCT03907800 | Unknown Phase 2

• 1 other identifier: RJBC1801
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (ypT0/is ypN0) rate

  Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.

  16 weeks (at the time of definitive surgery)

Secondary Outcomes (5)

• Invasive disease-free survival (IDFS)

  5 years

• Distant disease-free survival (DDFS)

  5 years

• Objective response rate (ORR)

  16 weeks (at the time of definitive surgery)

• Breast conservation rate

  16 weeks (at the time of definitive surgery)

• Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped

  during treatment (16 weeks)

Study Arms (1)

Nab-paclitaxel + Carboplatin ± Herceptin

EXPERIMENTAL

Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Herceptin

Interventions

Nab-paclitaxel DRUG

125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.

Nab-paclitaxel + Carboplatin ± Herceptin

Carboplatin DRUG

AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles

Nab-paclitaxel + Carboplatin ± Herceptin

Herceptin DRUG

In case of HER2-positive, patients receive Herceptin weekly during all cycles.

Nab-paclitaxel + Carboplatin ± Herceptin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
• Age at diagnosis ≥ 18 years, female.
• 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.
• cT2-4NanyM0 or cTanyN1-3M0
• ECOG ≤ 1, LVEF ≥ 55%.
• 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
• Patients must be available and compliant for treatment and follow-up.

You may not qualify if:

• Prior chemotherapy, endocrine therapy or radiation therapy for any malignancy.
• Known or suspected congestive heart failure (\> NYHA I)
• Currently active infection or severe symptomatic visceral disease.
• Definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
• rior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
• Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
• Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Carboplatin; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Li Zhu, Prof.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayi Wu, Dr.

CONTACT

0086-21-64370045; pinkscorpio@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)