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Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen (CAPneo)

Primary Purpose

Triple Negative Breast Cancer Patients

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

CAP

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer Patients focused on measuring locally advanced breast cancer, triple negative, cisplatin

Eligibility Criteria

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

Inclusion Criteria:

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.
Presence of measurable disease according to RECIST criteria.
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.
Performance Status (PS) of Eastern Cooperative Oncology Group (ECOG) ≤ 2.
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.
Adequate liver function, evidenced by bilirubin levels below 1.5 of normal values and liver enzyme levels less than 2.5 times normal.
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.
Preserved cardiac function assessed by Doppler echocardiography.
Socio-cultural ability to understand a clinical study and the need to Attend regularly for medical examinations and appointments.

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAP

Arm Description

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

Outcomes

Primary Outcome Measures

Pathological complete response (pCR)

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

Safety assessed according to NCI CTCAE

Safety was assessed according to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0.

Disease-free survival (DFS)

DFS was defined as time from surgery to disease recurrence or death from any cause

Overall survival (OS)

OS was defined as time from surgery to death from any cause.

Full Information

NCT ID

NCT03304756

First Posted

August 11, 2017

Last Updated

October 23, 2017

Sponsor

Instituto Nacional de Cancer, Brazil

Collaborators

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT03304756

Brief Title

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

Acronym

CAPneo

Official Title

Phase II Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer Patients With the CAP Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

December 15, 2007 (Actual)

Primary Completion Date

April 15, 2012 (Actual)

Study Completion Date

December 15, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Nacional de Cancer, Brazil

Collaborators

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Triple Negative Breast Cancer Patients

Keywords

locally advanced breast cancer, triple negative, cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAP

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CAP

Intervention Description

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 Measure Information:

Title

Pathological complete response (pCR)

Description

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)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Safety assessed according to NCI CTCAE

Description

Safety was assessed according to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0.

Time Frame

5 years follow-up

Title

Disease-free survival (DFS)

Description

DFS was defined as time from surgery to disease recurrence or death from any cause

Time Frame

5 years follow-up

Title

Overall survival (OS)

Description

OS was defined as time from surgery to death from any cause.

Time Frame

5 years follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Presence of measurable disease according to RECIST criteria. 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. Performance Status (PS) of Eastern Cooperative Oncology Group (ECOG) ≤ 2. 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. Adequate liver function, evidenced by bilirubin levels below 1.5 of normal values and liver enzyme levels less than 2.5 times normal. 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. Preserved cardiac function assessed by Doppler echocardiography. Socio-cultural ability to understand a clinical study and the need to Attend regularly for medical examinations and appointments. Exclusion Criteria: Patients with a history of previous neoplasia, except non melanoma skin cancer. Previously treatment of breast cancer with surgery, chemotherapy or Hormone therapy. Presence of metastatic disease Concomitant malignant neoplasm (including contralateral breast). Presence of uncontrolled heart, kidney or lung disease. Presence of uncontrolled diabetes mellitus. Pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Bines, Doctorate

Organizational Affiliation

Instituto Nacional de Cancer

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Otto Metzger, Oncologist

Organizational Affiliation

Medical oncologist in Boston, and affiliated with Dana-Farber Cancer Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

José Bines, Doctorate

Organizational Affiliation

Instituto Nacional de Cancer

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All data from this study was monitored by the GBECAM (Brazilian Group of studies on breast cancer) and the protocol approved by the research ethics committee of the National Cancer Institute. The collected data are archived in the research center, available for consultation in individual clinical records by patients, in addition to the source documents and folders with all regulatory material of the study. We are in the process of finalizing a scientific paper, to be published in an international magazine, in order to disseminate the results of the study.

Citations:

PubMed Identifier

29416986

Citation

Ferreira AR, Metzger-Filho O, Sarmento RMB, Bines J. Neoadjuvant Treatment of Stage IIB/III Triple Negative Breast Cancer with Cyclophosphamide, Doxorubicin, and Cisplatin (CAP Regimen): A Single Arm, Single Center Phase II Study (GBECAM 2008/02). Front Oncol. 2018 Jan 24;7:329. doi: 10.3389/fonc.2017.00329. eCollection 2017.

Results Reference

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

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