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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)

Study type: Interventional

Funder types: Other

Identifiers

NCT01396655

DA-PET-2010-0022299

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

docetaxel + doxorubicin

Experimental group

Description:

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

Treatment:

Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)