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Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

Primary Purpose

Triple Negative Breast Cancer

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Chemotherapeutic Agent

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Neoadjuvant Chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.
The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification.
At least one measurable objective lesion according to RECIST 1.1 criteria.
ECOG performance status of 0-1.
LVEF≥55%.
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.

Exclusion Criteria:

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.

Sites / Locations

Cancer Hospital/ Institute, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy

Arm Description

Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 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

The second endpoint includes the 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

NCT ID

NCT03799679

First Posted

January 8, 2019

Last Updated

January 9, 2019

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03799679

Brief Title

Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

Official Title

Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination With Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 26, 2018 (Actual)

Primary Completion Date

November 30, 2019 (Anticipated)

Study Completion Date

February 1, 2020 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label, single arm, two-stage Simon Design study for women with Triple 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 weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer. The primary endpoint of the study is to 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 60 patients. The duration of the study, from first patient visit to last patient visit will be approximately 19 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Cancer

Keywords

Neoadjuvant Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer. Patients will treated by Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide.

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy

Arm Type

Experimental

Arm Description

Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1* 12 cycles ( weekly), followed by epirubicin 90mg/m2, iv, d1 + cyclophosphamide 600mg/m2, iv, d1 * 4 cycles (14 days per cycle)

Intervention Type

Drug

Intervention Name(s)

Chemotherapeutic Agent

Intervention Description

Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide. Drug: Epirubicin 90 mg/m² given IV Drug: Cyclophosphamide 600 mg/m² given IV

Primary Outcome Measure Information:

Title

The primary endpoint is pathological complete remission (pCR)

Description

Time Frame

2 months

Secondary Outcome Measure Information:

Title

The second endpoint includes the objective response rate (ORR)

Description

Time Frame

2 months

Title

Breast conserving surgery(BCS) rate

Description

Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.

Time Frame

2 months

Title

Adverse events (AE)

Description

Time Frame

2 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. The expression of ER, PR, HER-2 was negative by immunohistochemistry (IHC), if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification. At least one measurable objective lesion according to RECIST 1.1 criteria. ECOG performance status of 0-1. LVEF≥55%. 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhimin Shao

Phone

18017312288

szm@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yin Liu

Phone

13818051895

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

Cancer Hospital/ Institute, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhimin Shao, M.D.

Phone

862164175590

Ext

8808

zhimingshao@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

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