Clinical trial · Interventional

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

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

NCT03304756CI-TRIAL-00030035CAPneocompletedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Triple Negative Breast Cancer Patients	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
CAP	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
CAP
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
interventionNames
1. Drug: CAP

Primary outcomes (1)

measure
Pathological complete response (pCR)
timeFrame
6 months
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)

Secondary outcomes (3)

measure
Safety assessed according to NCI CTCAE
timeFrame
5 years follow-up

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDFerreira 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