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

• ClinicalTrials.gov Identifier: NCT03799679
• Recruitment Status: Unknown
• First Posted: January 10, 2019
• Last Update Posted: January 10, 2019
• Sponsor: Fudan University
• Information provided by (Responsible Party): Zhimin Shao, Fudan University

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.

Condition or disease	Intervention/treatment	Phase
Triple Negative Breast Cancer	Drug: Chemotherapeutic Agent	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination With Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
• Actual Study Start Date: November 26, 2018
• Estimated Primary Completion Date: November 30, 2019
• Estimated Study Completion Date: February 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Chemotherapy; 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)	Drug: Chemotherapeutic Agent; 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

Outcome Measures

Primary Outcome Measures :

1. The primary endpoint is pathological complete remission (pCR) [ Time Frame: 2 months ]
   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 :

1. The second endpoint includes the objective response rate (ORR) [ Time Frame: 2 months ]
   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.
2. Breast conserving surgery(BCS) rate [ Time Frame: 2 months ]
   Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.
3. Adverse events (AE) [ Time Frame: 2 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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. 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.
4. At least one measurable objective lesion according to RECIST 1.1 criteria.
5. ECOG performance status of 0-1.
6. LVEF≥55%.
7. Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
8. 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.
9. 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.

Contacts and Locations

Contacts

Contact: Zhimin Shao; 18017312288; szm@163.com

Contact: Yin Liu; 13818051895

Locations

China, Shanghai

Cancer Hospital/ Institute, Fudan University; Recruiting

Shanghai, Shanghai, China, 200032

Contact: Zhimin Shao, M.D. 862164175590 ext 8808 zhimingshao@yahoo.com

Sponsors and Collaborators

Fudan University

Investigators

• Principal Investigator: Zhimin Shao; Fudan University

More Information

• Responsible Party: Zhimin Shao, professor, Fudan University
• ClinicalTrials.gov Identifier: NCT03799679
• Other Study ID Numbers: 1808189-7
• First Posted: January 10, 2019
• Last Update Posted: January 10, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhimin Shao, Fudan University:

Neoadjuvant Chemotherapy

Additional relevant MeSH terms:

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Antineoplastic Agents