Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer

NCT03799692 | Unknown Phase 4 DMC

• 1 other identifier: 1808189-8
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2 Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin. The primary objective of the trial is to evaluate of the efficacy and safety of Nanoparticle Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer. The primary endpoint of the study is to assess Pathological complete response rate（pCR）using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). The total number of patients to be included in this study is 78 patients. The duration of the study, from first patient visit to last patient visit will be approximately 12 months.

Conditions

HER-2 Negative Breast Cancer

Keywords

Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is pathological complete remission (pCR)

  Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.

  3 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  3 months

• Breast conserving surgery (BCS) rate

  3 months

• Adverse events (AE)

  3 months

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle).

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15. Drug: Carboplatin AUC=2 iv, d1, 8, 15.

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: from 18 to 70 years old, female.
• Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
• Immunohistochemical detection of ER+, PR+, HER-2 negative (if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification) and Ki-67 expression \>20% of patients;
• At least one measurable objective lesion according to RECIST 1.1 criteria.
• ECOG performance status of 0-1.
• Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
• Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
• Has good compliance with the planned treatment, understand the study process and sign written informed consent.

You may not qualify if:

• Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
• Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
• Severe systemic infection, or with other serious diseases.
• Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
• Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
• Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
• Have participated in other study studies within 30 days prior to the first dose of study drug.
• Patients who, in the opinion of the Investigator, are not suitable for participation in the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Department of Breast Surgery, Cancer Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhimin Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao

CONTACT

18017312288; szm@163.com

Yin Liu

CONTACT

13818051895; liuyinfudan@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: January 8, 2019
• First Posted: January 10, 2019
• Study Start: November 19, 2018
• Primary Completion: March 30, 2019
• Study Completion: July 30, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

CN (2)