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

NCT ID: NCT03304756

Last Updated: 2017-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-15
• Study Completion Date: 2014-12-15

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.

Conditions

Triple Negative Breast Cancer Patients

Keywords

locally advanced breast cancer; triple negative; cisplatin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CAP

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role: lead

Responsible Party

José Bines

Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Bines, Doctorate

Role: STUDY_CHAIR

Instituto Nacional de Cancer

Otto Metzger, Oncologist

Role: STUDY_DIRECTOR

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

José Bines, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancer

References

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.

Reference Type: DERIVED

PMID: 29416986 (View on PubMed)

Other Identifiers

Prot 82-07

Identifier Type: -

Identifier Source: org_study_id