Breast CancerNCT03749421
Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prosigna PAM-50 assay
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 10 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are considered possible candidates for neoadjuvant treatment, irrespective whether chemotherapy or endocrine therapy, by clinical-pathologic features.
Who may be able to join
- Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer
- ER or PR ≥ 1% by immunohistochemistry (IHC)
- HER2-negative status, according to guidelines by ASCO CAP guidelines:
- https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9751
- Tumor size ≥ 0.5cm (clinical or radiographic measurements)
- Any nodal status allowed
- Age > 18 years old
- Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician
Who cannot join
- ER-negative and PR-negative invasive breast cancer (< 1% by IHC)
- Known metastatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.
Read the detailed description
As the investigators understanding of how ER-positive breast cancer (a type of cancer in which the cells need the hormone estrogen to grow) improves, more treatment decisions are being tailored to an individual's unique genetic makeup. National medical guidelines now include the routine use of tumor profiling tests, like the Prosigna® assay, which look at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery.
Currently, the Prosigna® assay (also called PAM-50) is FDA approved as a tool that physicians can use to help make decisions about a patient's treatment after their breast surgery. In these cases, physicians run this test using tumor tissue from a patient's breast surgery. However, the Prosigna® assay is not approved for use preoperatively, or before surgery.
Previous studies showed that the Prosigna® assay was able to identify tumor types that were more likely to benefit from treatment before surgery (whether it's hormonal therapy or chemotherapy). In this study, the investigators will use tumor tissue from the participant's biopsy to run the Prosigna® assay. The test may give both the participant and the investigators more information about the best possible treatment option for the participant before surgery.
This study is being done to determine how Prosigna® assay results may affect the physician's choice of treatment before surgery and how well patients understand the test and its implications.
- Conditions
- Breast Cancer
- Being tested
- Prosigna PAM-50 assay
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosigna PAM-50 assayOther
Looks at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery
| Study group | Role | What they receive |
|---|---|---|
| Prosigna Assay | * Biopsy specimen will be subject to molecular profiling via the Prosigna PAM-50 assay
* The results of Prosigna assay will be provided to the study team in a standardized report.
* This report will include the patient's intrinsic subtype, ROR score, and general risk (high, intermediate, low). Receives: Other: Prosigna PAM-50 assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent to which the Prosigna test results will change physician's pre-test decision regarding neoadjuvant treatment of patients with stage II-III ER/PR+, HER2-negative breast cancer
Questionnaires will be used to record neoadjuvant treatment decisions pre- and post-test. Data will be summarized in a contingency table, and the extent to which decisions changed will be estimated as the proportion of discordant responses and reported with a two-sided exact 95% confidence interval.
Measured: 2 years
Secondary outcomes (4)
The association of pCR/RCB following neoadjuvant therapy with Risk of recurrence (ROR).
The association of the Prosigna test results to pathologic outcomes will be explored marginally in all patients who receive neoadjuvant treatment, and non-parametric Wilcoxon rank sum and Spearman test of correlation with two-sided alpha = 0.05 will be used to make inferences. Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes of response to neoadjuvant treatment.
Measured: 2 years
To assess if treatment change was based on ROR score, intrinsic subtype or both
Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes and response to neoadjuvant treatment. On the "Post-Prosigna Physician Questionnaire" physicians will be asked which of these item (ROR score, instrinsic subtype, or both) contributed to their neoadjuvant treatment decision-making.
Measured: 2 years
To evaluate physicians' confidence in their therapy before and after the test
Physicians will complete pre-test and post-test questionnaires that measure their confidence at each timepoint. The pre-test questionnaire will examine the percentage of physicians who are confident about their treatment recommendation. The same questions about confidence in diagnosis and treatment will be realized after Prosigna results and rates will be compared.
Measured: 2 years
To evaluate patients' confidence in their therapy before and after the test
Patients will complete pre-test and post-test questionnaires to measure their confidence at each timepoint. The pre-test questionnaire will examine the percentage of patients who understand their diagnosis and how Prosigna works and who are confident in treatment recommendation. The same question about diagnosis and treatment will be realized after Prosigna results and rates will be compared.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start21 Mar 2019
- Primary completion29 Nov 2023
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- NanoString Technologies, Inc.
- Responsible party
- Principal investigator, Sara Tolaney, MD, Dana-Farber Cancer Institute
- Investigators
- Sara Tolaney, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749421
- Sponsor's protocol ID
- 18-281
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2018
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corti C, Chu X, Exman P, Kline DM, Priedigkeit NM, Mayer EL, Waks AG, Hughes ME, Abravanel DL, Giordano A, Curigliano G, Lin NU, King TA, Jeselsohn RM, Manning DK, Dillon DA, Mittendorf EA, Tayob N, Tolaney SM. Impact of the Prosigna assay on neoadjuvant treatment decision-making in patients with early-stage HR-positive/HER2-negative breast cancer: a single-center prospective observational study. ESMO Open. 2025 Aug;10(8):105521. doi: 10.1016/j.esmoop.2025.105521. Epub 2025 Jul 25.
PubMed 40714511
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
- ClinicalTrials.gov ID
- NCT03749421
- Acronym / sponsor ID
- 18-281
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- NanoString Technologies, Inc.
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.
Detailed description
As the investigators understanding of how ER-positive breast cancer (a type of cancer in which the cells need the hormone estrogen to grow) improves, more treatment decisions are being tailored to an individual's unique genetic makeup. National medical guidelines now include the routine use of tumor profiling tests, like the Prosigna® assay, which look at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery.
Currently, the Prosigna® assay (also called PAM-50) is FDA approved as a tool that physicians can use to help make decisions about a patient's treatment after their breast surgery. In these cases, physicians run this test using tumor tissue from a patient's breast surgery. However, the Prosigna® assay is not approved for use preoperatively, or before surgery.
Previous studies showed that the Prosigna® assay was able to identify tumor types that were more likely to benefit from treatment before surgery (whether it's hormonal therapy or chemotherapy). In this study, the investigators will use tumor tissue from the participant's biopsy to run the Prosigna® assay. The test may give both the participant and the investigators more information about the best possible treatment option for the participant before surgery.
This study is being done to determine how Prosigna® assay results may affect the physician's choice of treatment before surgery and how well patients understand the test and its implications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosigna Assay | – | Other: Prosigna PAM-50 assay* Biopsy specimen will be subject to molecular profiling via the Prosigna PAM-50 assay * The results of Prosigna assay will be provided to the study team in a standardized report. * This report will include the patient's intrinsic subtype, ROR score, and general risk (high, intermediate, low). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are considered possible candidates for neoadjuvant treatment, irrespective whether chemotherapy or endocrine therapy, by clinical-pathologic features.
Key inclusion criteria (8 listed)
- Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer
- ER or PR ≥ 1% by immunohistochemistry (IHC)
- HER2-negative status, according to guidelines by ASCO CAP guidelines:
- https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9751
- Tumor size ≥ 0.5cm (clinical or radiographic measurements)
Key exclusion criteria (2 listed)
- ER-negative and PR-negative invasive breast cancer (< 1% by IHC)
- Known metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosigna PAM-50 assayLooks at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery | Other | Prosigna Assay |
Primary outcome
The extent to which the Prosigna test results will change physician's pre-test decision regarding neoadjuvant treatment of patients with stage II-III ER/PR+, HER2-negative breast cancer
Time frame: 2 years
Questionnaires will be used to record neoadjuvant treatment decisions pre- and post-test. Data will be summarized in a contingency table, and the extent to which decisions changed will be estimated as the proportion of discordant responses and reported with a two-sided exact 95% confidence interval.
4 secondary outcomes
The association of pCR/RCB following neoadjuvant therapy with Risk of recurrence (ROR).
Time frame: 2 years
To assess if treatment change was based on ROR score, intrinsic subtype or both
Time frame: 2 years
To evaluate physicians' confidence in their therapy before and after the test
Time frame: 2 years
To evaluate patients' confidence in their therapy before and after the test
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 40714511Corti C, Chu X, Exman P, Kline DM, Priedigkeit NM, Mayer EL, Waks AG, Hughes ME, Abravanel DL, Giordano A, Curigliano G, Lin NU, King TA, Jeselsohn RM, Manning DK, Dillon DA, Mittendorf EA, Tayob N, Tolaney SM. Impact of the Prosigna assay on neoadjuvant treatment decision-making in patients with early-stage HR-positive/HER2-negative breast cancer: a single-center prospective observational study. ESMO Open. 2025 Aug;10(8):105521. doi: 10.1016/j.esmoop.2025.105521. Epub 2025 Jul 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Tolaney, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The extent to which the Prosigna test results will change physician's pre-test decision regarding neoadjuvant treatment of patients with stage II-III ER/PR+, HER2-negative breast cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.