Clinical trial NCT02670577: Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
Official title: Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage I
stage II
HER2 positive
Triple Negative
Lead sponsor: Agendia
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 481
Sex: ALL
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: Stage I or II HR-positive, HER2-negative breast cancer patients AND T1a/b, N0/N1 (up to 1 node) Triple Negative, or HER2-positive breast cancer patients

Brief summary: The scope of this study is to measure the impact of MammaPrint on treatment in Hormone Receptor (HR)-positive HER2-negative breast cancer patients.

In addition, the impact of MammaPrint on treatment in patients with T1a/T1b and pN0/pN1 (up to 1 node), Triple Negative or HER2-positive tumors will be assessed.

Detailed description: Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint and BluePrint result is received and taken into consideration for the treatment plan. The clinical data are to be entered online. There will be 2 Case Report Forms (CRFs). Baseline clinical data and physician chemotherapy intention before knowing the MammaPrint and BluePrint result will be entered in CRF 1. After completion of CRF1, the MammaPrint and BluePrint result will be released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture physician chemotherapy intention after the MammaPrint and BluePrint result and the impact of these results.

A sample size of 331 patients is required to detect a 25% overall treatment change (5% significance and 95% power) in stage I and II HR-positive, HER2-negative patients receiving adjuvant therapy.

In addition at least 50 T1a/bN0/1 (up to 1 node) Triple Negative, at least 50 T1a/bN0/1 (up to 1 node) HER2-positive breast cancer patients, and at least 50 patients receiving neoadjuvant therapy will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Eligible to receive chemotherapy and endocrine therapy as defined by a good Karnofsky index (≥80) and no hematologic, cardiologic or hepatic contraindications, nor any impeding comorbidity
* Informed consent form signed on the same day or before enrollment
* ≥ 18 years of age at time of consent Per study arm
* Histologically proven invasive stage I and II breast cancer and Hormone Receptor positive (ER+ PR-, ER- PR+ or ER+ PR+) according to local standards \& HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)

IMPACt study; version 1 2015 September 1 Page 10 Axillary lymph node status: 0-3 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)

OR

Histologically proven invasive T1a or T1b breast cancer \& Hormone receptor negative (ER- and PR-) according to local standards \& HER2 negative: IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)

\& Axillary lymph node status: 0-1 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)

OR

Histologically proven invasive T1a or T1b breast cancer

\& Hormone receptor negative or positive (ER-PR-, ER+PR-, ER-PR+, ER+PR+) according to local standards

\& HER2 positive: IHC 3+, or FISH or other ISH amplified (locally assessed)

\& Axillary lymph node status: 0-1 involved (macro metastases i.e. \>2mm OR micro metastases i.e. \>0.2-2mm)

Exclusion Criteria:

* Previous diagnosis of breast malignancy unless disease free for 10 years
* Metastatic disease
* Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
* Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer

Primary outcomes:
measure: Change in Treatment Decision
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Women's Hospital
state: Florida
city: Decatur
country: United States
facility: The Cancer Center at DeKalb Medical
state: Georgia
city: Warrenville
country: United States
facility: Cadence Cancer Center
state: Illinois
city: Merrillville
country: United States
facility: Methodist Hospital
state: Indiana
city: Munster
country: United States
facility: Community Healthcare System
state: Indiana
city: Cumberland
country: United States
facility: Western Maryland Health System
state: Maryland
city: Lansing
country: United States
facility: Sparrow Cancer Center
state: Michigan
city: Belleville
country: United States
facility: Essex Oncology
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: St. Clair Hospital
state: Pennsylvania
city: Milwaukee
country: United States
facility: Aurora Cancer Care
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Mary's
state: Wisconsin
Study officials:
References:
citation: Soliman H, Shah V, Srkalovic G, Mahtani R, Levine E, Mavromatis B, Srinivasiah J, Kassar M, Gabordi R, Qamar R, Untch S, Kling HM, Treece T, Audeh W. MammaPrint guides treatment decisions in breast Cancer: results of the IMPACt trial. BMC Cancer. 2020 Jan 31;20(1):81. doi: 10.1186/s12885-020-6534-z.