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Completed

NCT Number: NCT01396655

PET in Breast Cancer Receiving Neoadjuvant Chemotherapy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • history of other cancer
  • active infection
  • pregnancy
  • psychologic disease
  • uncontrolled heart diseases
  • male

Treatment and study plan

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

Drug

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.

Primary outcomes

  1. pathologic complete response

    Time frame: 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 outcomes

  1. survival (Relapse-free survival, overall survival)

    Time frame: 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy

    Relapse-free survival, overall survival were estimated by Kaplan-Meier product limit methods

  2. early metabolic response

    Time frame: 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

  3. predictive factors

    Time frame: 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

  4. hematologic toxicity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Acronym: DA-PET

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Jul 19, 2011
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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