Back to resultsAlbumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer
Primary Purpose
HER-2 Negative Breast Cancer
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for HER-2 Negative Breast Cancer focused on measuring Neoadjuvant Chemotherapy
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.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
- Department of Breast Surgery, Cancer Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy
Arm Description
Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Objective response rate (ORR)
The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases.
Breast conserving surgery (BCS) rate
Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.
Adverse events (AE)
Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03799692
Brief Title
Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer
Official Title
Clinical Trial of Nanoparticle Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Anticipated)
Study Completion Date
July 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER-2 Negative Breast Cancer
Keywords
Neoadjuvant Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle).
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15.
Drug: Carboplatin AUC=2 iv, d1, 8, 15.
Primary Outcome Measure Information:
Title
The primary endpoint is pathological complete remission (pCR)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases.
Time Frame
3 months
Title
Breast conserving surgery (BCS) rate
Description
Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.
Time Frame
3 months
Title
Adverse events (AE)
Description
Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhimin Shao
Phone
18017312288
Email
szm@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yin Liu
Phone
13818051895
Email
liuyinfudan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Min Shao, MD.PhD.
Phone
13601637369
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zhi-Min Shao, MD.PhD.
Facility Name
Department of Breast Surgery, Cancer Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao
Phone
86(21)64175590
Ext
88807
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zhimin Shao
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer
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