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

Last updated: October 26, 2022
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT03907800
RJBC1801
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  1. Written informed consent for all study according to local regulatory requirementsprior 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, totalbilirubin ≤ 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

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 hypersensitivityreaction 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 treatedbasalioma of the skin, pTis of the cervix uteri.
  6. Participation in another clinical trial with any investigational, not marketed drugwithin 30 days prior to study entry.
  7. Pregnant or lactating patients. Patients of childbearing potential must implementadequate non-hormonal contraceptive measures (barrier methods, intrauterinecontraceptive devices, sterilization) during study treatment.

Study Design

Total Participants: 100
Study Start date:
April 01, 2019
Estimated Completion Date:
October 31, 2022

Connect with a study center

  • Ruijin Hospital

    Shanghai, 200025
    China

    Active - Recruiting

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