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Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 CenterLebanon, New Hampshire  03756-0002
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868