PET in Breast Cancer Receiving Neoadjuvant Chemotherapy

Breast Cancer Clinical Trial

— DA-PET  

Official title:

Analysis of Clinical Outcome, Predictive and Prognostic Factors of Therapeutic Responses in Patients Who Treated With Doxorubicin & Docetaxel Neoadjuvant Chemotherapy in Clinical Stage II or III Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396655
• Other study ID #: DA-PET-2010-0022299
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2011
• Last updated: July 15, 2011
• Start date: July 2006
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Seoul National University Hospital:Korea
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2011
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Exclusion Criteria:

1. history of other cancer

2. active infection

3. pregnancy

4. psychologic disease

5. uncontrolled heart diseases

6. male

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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. After three cycles of neoadjuvant chemotherapy, the patients were re-evaluated for response and underwent curative surgery. Radiologic response was evaluated using breast magnetic resonance imaging (MRI) for the primary breast tumor and chest computed tomography (CT) for axillary, supraclavicular, internal mammary lymph nodes with RECIST criteria. Both breast MRI and chest CT were performed in all the 78 patients. Subsequently, the patients received three more cycles of docetaxel and doxorubicin as an adjuvant chemotherapy, followed by hormonal or radiation therapy, if indicated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response	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.	after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)	No
Secondary	survival (Relapse-free survival, overall survival)	Relapse-free survival, overall survival were estimated by Kaplan-Meier product limit methods	2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy	No
Secondary	early metabolic response	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	before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle)	No
Secondary	predictive factors	Predictive factors for pathologic complete response were analyzed using univariate and multivariate logistic regression analysis	after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)	No
Secondary	hematologic toxicity	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.	every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy)	Yes