PET in Breast Cancer Receiving Neoadjuvant Chemotherapy (DA-PET)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: docetaxel + doxorubicin; The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Bhumsuk Keam, MD, Seoul National University Hospital; Principal Investigator: Seock-Ah Im, MD PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• Keam B, Im SA, Koh Y, Han SW, Oh DY, Cho N, Kim JH, Han W, Kang KW, Moon WK, Kim TY, Park IA, Noh DY, Chung JK, Bang YJ. Early metabolic response using FDG PET/CT and molecular phenotypes of breast cancer treated with neoadjuvant chemotherapy. BMC Cancer. 2011 Oct 20;11:452. doi: 10.1186/1471-2407-11-452.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: July 15, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): July 19, 2011
• Last Update Submitted That Met QC Criteria: July 15, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: breast cancer; neoadjuvant chemotherapy; FDG PET; molecular marker; locally advanced breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Doxorubicin
• Other Study ID Numbers: DA-PET-2010-0022299