OctavaPink for Women With Dense Breast After Negative Mammography

The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). The device is intended to increase breast cancer detection in the described patient population. Based upon the result of OctavaPink, the patient will be further evaluated by their physician.

This is a multicenter, prospective study containing 3 parts:

Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as follows:

Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not affect the treatment of the participants. Part 1A is an internal part done by EventusDx and no statistical evaluation is needed.

Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70% sensitivity.

Part 1B will assess the properties of the OctavaPink test using cases and controls obtained via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control status before using the test to affect clinical management of patients.

Objectives:

(i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same properties in the subset of cases with invasive cancer (IDC and ILC).

(ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.

Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a positive OctavaPink test result in the dense breast negative mammography population.

Objectives:

(i) To compare the yield of cancer detection via MRI/biopsy among women with a positive OctavaPink test versus a negative OctavaPink test result.

(ii) To estimate the proportion of patients who are positive for the test in the target population

Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with dense breasts and negative mammography.

Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and negative mammography that is broadly consistent with that found in the dense breast population (but not necessarily negative mammogram) in Parts 1A and 1B.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with dense breast tissue according to ACR criteria, (BIRADS composition/density 3 or 4), or with specific area of high density behind the nipple.
* Subject with current mammography BIRADS assessment category other than 3.
* Signed inform consent form.

Additional inclusion criteria for Part 1A and Part 1B cases and Part 3 cases

• Subjects with current biopsy/surgery proven breast cancer.

Additional inclusion criteria for Part 1A controls, Part 1B controls • Subjects with current negative mammography (BIRADS assessment category 1 or 2).

Additional inclusion criteria for Part 2

• Subjects with current negative mammography (BIRADS assessment category 1 or 2). All will perform an additional 1 year (12-18 months) up mammography to verify negative results.

Additional inclusion criteria for Part 3 • Enriched patient population - Subjects with current/recent (less than 12 months) negative mammography (BIRADS assessment category 1 or 2). Mammography evaluation can be performed after recruiting.

Exclusion Criteria:

* Previous or concurrent malignancies of any type except for basal cell carcinoma of the skin, squamous-cell carcinoma of the skin or cervical carcinoma in situ.
* Previous or current ADH, ALH, LCIS.
* Autoimmune disorders diagnosed subjects.
* Hematological malignancies.
* Subjects under active chemotherapy treatment or chemotherapy in the past 6 months.
* Steroid treatment in the past 3 months.
* Subject undergoing immunosuppressive treatments.
* Subject with current mammography BIRADS assessment category of 3.
* Pregnancy at time of recruitment.
* Doctor medical judgment that prohibits participation in the study.
* Participating in a parallel clinical study that involves drug treatment, or may influence the course of this clinical trial.

Additional exclusion criteria for Part 3

• Subjects with current mammography BIRADS assessment other than 1 or 2.