Clinical trial NCT01850628: NSABP Biospecimen Discovery Project
Official title: NSABP Biospecimen Discovery Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: National Surgical Adjuvant Breast and Bowel Project (NSABP)
paclitaxel
trastuzumab
pertuzumab
HER2 positive (human epidermal growth factor receptor 2)
Proteomics
Neoadjuvant Therapy
Anthracycline therapy
Locally advanced
Operable
Biomarkers
Lead sponsor: NSABP Foundation Inc
Sponsor class: NETWORK
Collaborators: name: Breast Cancer Research Foundation
name: Washington University School of Medicine
First posted: 2013-05-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with locally advanced, HER2-positive breast cancer from selected sites in the United States

Brief summary: This study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA and RNA sequencing.

Detailed description: This study will be conducted at select NSABP sites where investigators are willing to give paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination as the initial component of neoadjuvant therapy as a pilot for a comprehensive 'omics approach using next generation sequencing and protein expression and post-translational modification analysis using mass spectrometry (MS) based and Reverse Phase Protein Array-based proteomics. Tumor samples will be obtained at baseline and 48 to 72 hours after initial drug treatment to study variation in the biological responses to these agents. The study of tumors both before and early after the first treatment probes the biological responses to treatment and is rich source of predictive biomarkers.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
* The breast cancer must be HER2-positive based on current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer.
* The patient must have a mass in the breast measuring greater than or equal to 2.0 cm by physical exam and/or ultrasound that is accessible and safe for repeat biopsy. Patients with a diagnosis of inflammatory breast cancer are eligible if there is a palpable or detectable breast mass that is accessible and safe for repeat biopsy.
* Planned initial treatment with a combination of paclitaxel and trastuzumab or a trastuzumab/pertuzumab-based combination. Schedule for paclitaxel/trastuzumab or trastuzumab/pertuzumab administration is per the investigator.

Exclusion Criteria:

* Excisional biopsy or lumpectomy performed prior to registration.
* Previous therapy with chemotherapy or targeted therapy for any malignancy.
* Treatment, including radiation therapy (RT), chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to registration.
* Other nonmalignant systemic disease that would preclude the patient from receiving chemotherapy and targeted therapy.

Primary outcomes:
measure: Measure variation in biologic response by comprehensive tumor 'omics profiling in patients receiving an upfront regimen containing paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination
timeFrame: blood and tissue specimens will be collected at the time of diagnosis; prior to treatment; 48 and 72 hours following first dose of treatment; and following surgery, if tumor remains.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: NSABP Foundation Inc
name: Norman Wolmark, MD
role: PRINCIPAL_INVESTIGATOR
References: