Clinical trial · Observational
Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT04835597CI-TRIAL-00080165terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB Study Closure
Summary
Brief summary (as posted)
This study assesses the performance status in stage I-III triple negative breast cancer patients who are receiving neoadjuvant chemotherapy. Information collected in this study may help doctors learn if movement and fitness trackers can be used to predict side effects in cancer patients receiving chemotherapy.
Conditions
Conditions (20)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IA Breast Cancer AJCC v8 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Assessment | Behavioral | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (movement assessment, medical data collection)
- description
- Patients complete movement assessment 5-15 days prior to the initiation of neoadjuvant chemotherapy and at day 1 of neoadjuvant chemotherapy. Patients' SAE data is collected. Patients are observed during their neoadjuvant chemotherapy for up to 6 months.
- interventionNames
- Behavioral: Behavioral Assessment
- Other: Electronic Health Record Review
Primary outcomes (1)
- measure
- The number of non-hematologic serious adverse events occurring during neoadjuvant chemotherapy (i.e. correlate Microsoft motion tracking data and baseline metabolic equivalents [METs] group with incidence of serious adverse events)
- timeFrame
- Up to 6 months
Secondary outcomes (5)
- measure
- The number of severe adverse event (SAE)s
- timeFrame
- During the final 3 months of neoadjuvant chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathologically confirmed breast cancer with any receptor status, who will receive neoadjuvant chemotherapy. Patients with denovo oligo-metastatic disease, where the intent of therapy is curative with incorporation of local therapy (surgery/radiation to the breast and/or metastatic sites) are also eligible. * Age \>= 18 years * Ability to understand and the willingness to sign a written informed consent * Willingness to wear sensors to track physical activity, global positioning system (GPS) location, and provide symptom ratings each night during the screening period of their clinical trial and 180 days after starting treatments * Able to read English, Spanish, or Mandarin to complete patient reported outcomes * Able to ambulate without an assistive device Exclusion Criteria: * Missing lower limbs * Known movement disorder such as Parkinson's disease, choreo-athetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy
References
Publications (0)
Data not yet available
No reference posted for this study.