Status:
COMPLETED
Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Triple Negative Breast Cancer Patients
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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/m...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03304756
Start Date
December 15 2007
End Date
December 15 2014
Last Update
October 25 2017
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