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

NCT03304756 | Completed Phase 2 DMC

• 1 other identifier: Prot 82-07
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Triple Negative Breast Cancer Patients

Keywords

locally advanced breast cancer; triple negative; cisplatin

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (3)

• Safety assessed according to NCI CTCAE

  5 years follow-up

• Disease-free survival (DFS)

  5 years follow-up

• Overall survival (OS)

  5 years follow-up

Study Arms (1)

CAP

EXPERIMENTAL

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

Drug: CAP

Interventions

CAP 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

CAP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead
• Dana-Farber Cancer Institute: collaborator

Related Publications (1)

• 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.

  PMID: 29416986 DERIVED

Study Officials

• José Bines, Doctorate

  Instituto Nacional de Cancer

  STUDY CHAIR

• Otto Metzger, Oncologist

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

  STUDY DIRECTOR

• José Bines, Doctorate

  Instituto Nacional de Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: October 9, 2017
• Study Start: December 15, 2007
• Primary Completion: April 15, 2012
• Study Completion: December 15, 2014
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR