Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:10/15/2017
Start Date:December 2015
End Date:October 10, 2017

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A Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients Who Are Candidates for Genomic Testing

This multicenter, prospectively designed study examines whether the Prosigna score influences
physician and patient adjuvant treatment selection over and above currently used prognostic
factors. This study also examines the impact of the test results on patients' reported
outcomes, including their decisional conflict status and anxiety levels.

The primary objective of this study is to assess the extent to which the Prosigna test
results affect the medical oncologist's treatment recommendations regarding adjuvant
chemotherapy and actual treatments received for patients with early stage breast cancer
conventionally considered candidates for genomic testing based on current treatment
guidelines. The oncologist's initial recommendations will be based on the utilization of
tools or algorithms based on clinical and pathologic factors. No genomic tools will be used
in the initial assessment. Changes in recommendation after availability of Prosigna test
results will include (1) hormonal therapy alone or (2) hormonal therapy plus chemotherapy,
and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the
test.

Inclusion Criteria:

- Surgically resected node-negative, estrogen receptor-positive, HER2-negative
early-stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)

1. Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more
than 1% of stained tumor cells will be considered positive.

2. HER2 status will be evaluated by IHC and/or by in-situ fluorescence hybridization
(0 or 1+, or 2+ will be considered negative in the absence of in-situ
fluorescence hybridization).

- Postmenopausal females, which is defined as:

1. Natural Amenorrhea > 12 months, regardless of age

2. Bilateral oophorectomy, regardless of age (the oophorectomy must have been
carried out at least 4 weeks before entering the study)

3. Radiological castration with amenorrhea > 3 months, regardless of age

4. Hysterectomy and postmenopausal blood levels of FSH/LH

- Able to give informed consent

- Eligible for treatment of breast cancer with adjuvant chemotherapy, as determined by
the treating physician

- ECOG performance status of 0 or 1

Exclusion Criteria:

- Tumor specimen from core needle biopsy (CNB)

- Tumor stage T3-T4

- Non-invasive breast cancer (e.g., Paget's disease, DCIS)

- Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+)

- Tumors that are estrogen receptor (ER) negative or HER2-positive

- Have metastatic disease

- Have received another genomic test for prognosis of early breast cancer (i.e.,
Oncotype Dx, Mammaprint, or BCI)

- Unable to give informed consent

- Unable to complete patient reported outcome surveys

- Have contraindications for adjuvant chemotherapy, as determined by the treating
physician

o Age, performance status, significant comorbidities, etc.

- ECOG performance status > 1
We found this trial at
4
sites
6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Principal Investigator: Ralph Boccia, MD
Phone: 301-571-2016
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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East Setauket, New York 11733
Principal Investigator: Jeffrey L Vacirca, MD
Phone: 631-751-3000
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Fort Myers, Florida 33913
Principal Investigator: Lowel Hart, MD
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Scarborough, Maine 04074
Principal Investigator: TRACEY WEISBERG, MD
Phone: 207-396-7634
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Scarborough, ME
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