PET in Breast Cancer Receiving Neoadjuvant Chemotherapy

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)

• Registration Number: NCT01396655
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer.

The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2008-09
• Study Completion: 2011-06
• Study First Submitted: 2011-06-16
• Status Verified: 2011-07
• Study First Submitted QC: 2011-07-15
• Last Update Submitted: 2011-07-15
• Study First Posted: 2011-07-19
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

1. pathologically-confirmed breast cancer by core needle biopsy,
2. initial clinical stage II or III,
3. objective measurable lesion,
4. ECOG performance 0~2,
5. previously untreated,
6. adequate bone marrow, hepatic, cardiac, and renal functions
7. age 20~70
8. agreement with this trial, and written informed consent

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Exclusion Criteria

1. history of other cancer
2. active infection
3. pregnancy
4. psychologic disease
5. uncontrolled heart diseases
6. male

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel + doxorubicin	docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)	The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks.

Primary Outcome Measures

Name	Time	Method
pathologic complete response	after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)	The primary end point of this trial was evaluating pathologic complete response (pCR) rate. After 3 cycles of neoadjuvant chemotherapy, patients were undertook breast surgery. Using post operative pathology specimen, we evaluated pathologic response and calculated pCR rate.

Secondary Outcome Measures

Name	Time	Method
survival (Relapse-free survival, overall survival)	2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy	Relapse-free survival, overall survival were estimated by Kaplan-Meier product limit methods
early metabolic response	before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle)	Early metabolic response were evaluated by serial FDG PET/CT before and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle). Declining of SUV were calculated
predictive factors	after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)	Predictive factors for pathologic complete response were analyzed using univariate and multivariate logistic regression analysis
hematologic toxicity	every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy)	Hematologic toxicities are evaluated every q 3weeks during chemotherapy. Neutropenia,thrombocytopenia, and anemia are evaluated during chemotherapy (per cycles) by NCI CTCAE v3.0 criteria.