Clinical trial NCT02596724: TME Neoadjuvant Breast Registry
Official title: TME Neoadjuvant Breast Registry (The NEAT Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Breast Neoplasms
Keywords: Breast Cancer
Neoadjuvant therapy for breast cancer
Lead sponsor: Targeted Medical Education
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy. Aged 18-90.

Brief summary: Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.

Detailed description: Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded.

Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website.

All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy
* Ages 18-90
* Written informed consent

Exclusion Criteria:

* Patients who have had excisional biopsy or axillary dissection
* Patients with confirmed metastatic disease
* Patients who have had recent chemotherapy

Primary outcomes:
measure: Pathologic response and/or endocrine sensitivity
timeFrame: Post surgical treatment--usually within 4 months
Secondary outcomes:
measure: Metastasis-free/relapse-free survival in molecular subgroups
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Valley Medical Oncology Consultants
state: California
city: Allentown
country: United States
facility: Coordinated Health Breast Care Specialists
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Breast Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas Surgical Group
state: Texas
Study officials:
affiliation: Nashville Breast Center
name: Pat Whitworth, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dallas Surgical Group
name: Peter Beitsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: