Clinical trial · Interventional
Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy
Monitoring Response After The First Chemotherapy Cycle In Newly Diagnosed Breast Cancer As A Guide For Neoadjuvant Therapy
NCT01038258CI-TRIAL-00007413PETBreastunknownN/AClinicalTrials.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)
A PET scan drop less than 20% in SUVs or below a certain absolute SUV value after the first course of neoadjuvant chemotherapy can predict pathological response, and could in the future lead to an early surgical intervention.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Breast Carcinoma | Breast Inflammatory Carcinoma | ALIAS | 0.90 |
| Invasive Ductal Carcinoma | Invasive Breast Carcinoma of No Special Type | ALIAS | 0.90 |
| Lobular Breast Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET scan after course 1 and surgery after 8 courses | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- No arms
- description
- No arms
- interventionNames
- Procedure: PET scan after course 1 and surgery after 8 courses
Primary outcomes (1)
- measure
- Pathologic response
- timeFrame
- After 1st course of chemo and after definitive surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recently diagnosed breast carcinoma that will receive neoadjuvant chemotherapy based on: Tumors size greater than 2 cms; Locally advanced tumors, Tumors close to or invading chest wall or areola and/or Inflammatory Breast cancer. * 18 years of age. * Available for follow-up visits * Able to comply with study requirements. * Have signed an IRB approved written informed consent form Exclusion Criteria: * Any significant medical or psychiatric illness, which would prevent the patient from giving informed consent or following the study procedures. * Pregnant and Nursing women. * No restriction will be placed on the chemotherapy regimen used although we expect that most patients will receive Anthracycline based regimens.
References
Publications (0)
Data not yet available
No reference posted for this study.