Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen

Phase 2

Completed

• Conditions: Triple Negative Breast Cancer Patients
• Interventions: Drug: CAP

• Registration Number: NCT03304756
• Lead Sponsor: Instituto Nacional de Cancer, Brazil

Brief Summary

This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days was further provided for 4 cycles. Primary outcome was pathological complete response in the breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and overall survival.

Detailed Description

This is a non-randomized, open-label, single arm, single center, phase II clinical trial. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2, intravenous \[IV\], day 1) in combination with doxorubicin (50 mg/m2, IV, day 1) and cyclophosphamide (500 mg/m2, IV, day 1) every 21 days and for a total of 6 cycles (CAP regimen). Subsequent mastectomy plus axillary lymph node dissection was performed. Pathological specimen was analyzed to assess tumor response in the breast and axilla. Adjuvant chemotherapy consisting of docetaxel (75 mg/m2, IV) every 21 days was further provided for 4 cycles. In case of tumor progression during neoadjuvant treatment, CAP was discontinued and additional local or systemic treatment was provided at the discretion of the investigator. The protocol was approved by the institutional review board of National Cancer Institute - Brazil. All patients provided written informed consent. The Brazilian Group of Breast Cancer Studies (GBECAM) and National Cancer Institute -Brazil were the academic sponsors and National Cancer Institute- Brazil was the funding source of the trial.

Study Timeline

• Study Start: 2007-12-15
• Primary Completion: 2012-04-15
• Study Completion: 2014-12-15
• Study First Submitted: 2017-08-11
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-09
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

1. Female patients with locally advanced breast cancer (stages IIB, IIIA and IIIB), confirmed anatomopathologically, with hormonal receptors (Estrogen and / or progesterone) and ERBB2 negative to the immunohistochemical study pattern.
2. Presence of measurable disease according to RECIST criteria.
3. Staging with chest X-ray, abdominal ultrasound and bone scintigraphy Without evidence of metastatic disease. Capture in bone scintigraphy should be Evaluated by simple radiographs.
4. Performance Status (PS) of Eastern Cooperative Oncology Group (ECOG) ≤ 2.
5. Adequate haematological function, evidenced by higher hemoglobin level Than 9 g / dl, neutrophil count greater than 1,500 / mm 3 and platelet count greater than 100,000 / mm 3.
6. Adequate liver function, evidenced by bilirubin levels below 1.5 of normal values and liver enzyme levels less than 2.5 times normal.
7. Adequate renal function, evidenced by creatinine levels lower than 1.5 times normal value and / or estimated creatinine clearance (Cockroft) greater than 50 ml / min.
8. Preserved cardiac function assessed by Doppler echocardiography.
9. Socio-cultural ability to understand a clinical study and the need to Attend regularly for medical examinations and appointments.

Exclusion Criteria

1. Patients with a history of previous neoplasia, except non melanoma skin cancer.
2. Previously treatment of breast cancer with surgery, chemotherapy or Hormone therapy.
3. Presence of metastatic disease
4. Concomitant malignant neoplasm (including contralateral breast).
5. Presence of uncontrolled heart, kidney or lung disease.
6. Presence of uncontrolled diabetes mellitus.
7. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAP	CAP	Cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR)	6 months	Pathological complete response (pCR) assessed by the local pathology lab, and defined as the absence of tumor (invasive and/or in situ) both in the breast and axilla (ypT0 ypN0)

Secondary Outcome Measures

Name	Time	Method
Safety assessed according to NCI CTCAE	5 years follow-up	Safety was assessed according to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0.
Overall survival (OS)	5 years follow-up	OS was defined as time from surgery to death from any cause.
Disease-free survival (DFS)	5 years follow-up	DFS was defined as time from surgery to disease recurrence or death from any cause