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

NCT ID: NCT03799692

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2019-07-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy

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

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

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

Drug: Carboplatin AUC=2 iv, d1, 8, 15.

Interventions

Chemotherapy

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

Drug: Carboplatin AUC=2 iv, d1, 8, 15.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1.Age: from 18 to 70 years old, female.
• 2.Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
• 3.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;
• 4.At least one measurable objective lesion according to RECIST 1.1 criteria.
• 5.ECOG performance status of 0-1.
• 6.Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
• 7.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.
• 8.Has good compliance with the planned treatment, understand the study process and sign written informed consent.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhimin Shao

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Department of Breast Surgery, Cancer Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhimin Shao

Role: CONTACT

szm@163.com

18017312288

Yin Liu

Role: CONTACT

liuyinfudan@163.com

13818051895

Facility Contacts

Zhi-Min Shao, MD.PhD.

Role: primary

zhimingshao@yahoo.com

13601637369

Zhimin Shao

Role: primary

zhimingshao@yahoo.com

86(21)64175590 ext. 88807

Other Identifiers

1808189-8

Identifier Type: -

Identifier Source: org_study_id