Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)
18 Years
N/A
Female
Breast Cancer
Trial Information
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)
OBJECTIVES:
Primary
- To determine whether the percentage change in the diffuse optical spectroscopy imaging
(DOSI) measurement of the tumor/normal (T/N) tissue optical index (TOI) from baseline
to mid-therapy is predictive of the final pathologic response of the primary tumor in
patients with locally advanced breast cancer treated with neoadjuvant chemotherapy.
Secondary
- To investigate whether change of TOI measurements from baseline to post-therapy are
predictive of the final pathologic response in these patients treated with this
regimen.
- To investigate whether baseline TOI measurements are associated with final pathologic
response in patients treated with this regimen.
- To investigate whether TOI measurements at baseline, change from baseline to
mid-therapy, and change from baseline to post-therapy correlate with available MRI
volumetric imaging measurements.
- To investigate whether changes on TOI measurements from baseline to mid-therapy, and
from baseline to post-therapy, correlate with other standard-of-care imaging and/or any
MRI-imaging measurements.
- To explore whether additional optical endpoints and indices obtained during DOSI
measurements can be used to predict final pathologic response in patients treated with
this regimen.
- To determine a cutpoint for the percent change of TOI from baseline to mid-therapy that
is predictive of pathological complete response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo diffuse optical spectroscopy imaging (DOSI) at baseline, 5-10 days after
initiation of neoadjuvant chemotherapy, during early- and mid-neoadjuvant therapy, and
within 21 days after completion of neoadjuvant therapy. Results are compared to
standard-of-care imaging (e.g., MRI, ultrasound, mammography). Patients then undergo
surgery.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of invasive breast cancer by clinical breast examination, by standard of
care diagnostic imaging, or by initial tissue biopsy (confirmed by the local site
pathologist)
- Locally advanced disease
- Planned primary systemic (neoadjuvant) chemotherapy and surgical resection of
residual primary tumor (mastectomy or lumpectomy/breast conservation) following
completion of neoadjuvant chemotherapy
- No contraindications for primary chemotherapy
- Tumor size ≥ 2 cm by imaging or estimated by physical exam
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- WBC ≥ 3,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine normal OR creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled intercurrent illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness and/or social situations that would limit compliance with
study requirements
- Not medically unstable
- At least 5 years since prior malignancy except basal cell or squamous cell carcinoma
of the skin, or in situ carcinoma of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy, radiotherapy, or surgery to involved breast, including hormone
therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Relationship between pathological complete response and percent change from baseline to post-therapy in tissue optical index (TOI) tumor to normal ratio
Outcome Time Frame:
Until surgery
Safety Issue:
No
Principal Investigator
Bruce J. Tromberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Chao Family Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000674337
NCT ID:
NCT01217385
Start Date:
March 2011
Completion Date:
Related Keywords:
- Breast Cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
