Clinical trial · Observational
PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer
Early Assessment of Response to Targeted Breast Cancer Therapy
NCT00362973CI-TRIAL-00025273completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as PET scans, may help in learning how well hormone therapy and trastuzumab work to kill breast cancer cells and allow doctors to plan better treatment. PURPOSE: This clinical trial is studying how well PET scans work in assessing response to treatment in patients receiving hormone therapy or trastuzumab for breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| needle biopsy | Procedure | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| radionuclide imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hormone Receptor Positive Breast Cancer
- description
- Patients with hormone receptor positive primary, recurrent or metastatic breast cancer with a treatment plan that involves (neoadjuvant) administration of aromatase inhibitor and ovarian suppression (if premenopausal).
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: needle biopsy
- Procedure: positron emission tomography
- Procedure: radionuclide imaging
- Radiation: fludeoxyglucose F 18
- label
- HER-2/neu Positive Breast Cancer
- description
- Patients with HER-2/neu positive primary, recurrent or metastatic breast cancer with a treatment plan that involves (neoadjuvant) administration of trastuzumab.
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: needle biopsy
- Procedure: positron emission tomography
- Procedure: radionuclide imaging
- Radiation: fludeoxyglucose F 18
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed breast cancer with 1 of the following: * Hormone receptor-positive disease and planning to receive treatment with neoadjuvant aromatase inhibitor and ovarian suppression therapy (if premenopausal) * Recurrent and/or metastatic hormone receptor-positive disease and planning to receive treatment with an aromatase inhibitor and ovarian suppression therapy (if premenopausal) * Metastatic HER-2/neu-positive disease and planning to receive treatment with neoadjuvant trastuzumab (Herceptin®) * Recurrent HER-2/neu-positive disease and planning to receive treatment with trastuzumab (Herceptin®) * Tumor must be accessible for biopsy and assessable for response * Tissue block must be available for review of experimental markers or patient must be willing to undergo biopsy * Evaluable disease by FDG-PET scan * Available for positron emission tomography (PET) imaging with a clinical indication for PET scan * May aslo be enrolled on an experimental nuclear imaging study of 16α-fluoroestradiol F 18-PET scan (if hormone positive) * Concurrently receiving treatment (hormonal or other) for breast cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: * Female or male * Postmenopausal or premenopausal * Life expectancy ≥ 2 months * No uncontrolled diabetes mellitus or other comorbidity that would preclude imaging * Not pregnant * Negative pregnancy test * Able to tolerate scanning (e.g., no claustrophobia or severe pain) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent participation on another clinical study or other imaging studies allowed
References
Publications (0)
Data not yet available
No reference posted for this study.