Ductal Breast Carcinoma in SituNCT01293032
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
A study testing Neoadjuvant Therapy, Therapeutic Conventional Surgery and Laboratory Biomarker Analysis in people with Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, run by Virginia Commonwealth University at 8 sites in 2 countries.
Trial summary
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with hormone responsive cancers that were not suitable for… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage II Breast Cancer
- What is being tested?
- Neoadjuvant Therapy, Therapeutic Conventional Surgery and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy
- The patient must have signed and dated an institutional review board (IRB) approved consent form that conforms to federal and institutional guidelines
- The patient must be female
- The patient must be greater than or equal to 18 years old
- The patient must have an Eastern Cooperative Oncology Group Score (ECOG) performance status of 0 or 1
- The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy
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- The primary breast tumor must be >= 2 cm by physical exam or imaging
- Ipsilateral axillary lymph nodes must be evaluated by imaging (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed.
- The tumor must have been determined to be HER2-negative as follows:
- Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to Chromosome 17 centromere (CEP17) must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or
- Chromogenic in situ hybridization (CISH) is performed, the result must indicate a HER2 gene copy number of < 6 per nucleus; or
- Immunohistochemistry (IHC) 0-1+; or
- IHC 2+ and FISH-negative or CISH-negative
- The tumor must have been determined to be ER+ and/or progesterone positive (PgR+) defined as > 10% tumor staining by immunohistochemistry
- The patient must have been evaluated by a treating physician, reviewed and discussed by the multi-disciplinary breast team, and considered to be a candidate for chemotherapy
Who cannot join
- FNA alone to diagnose the primary tumor
- Excisional biopsy or lumpectomy performed prior to randomization
- Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to registration
- Tumors clinically staged as including inflammatory breast cancer
- Ipsilateral cN2b or cN3 disease (patients with cN1 or cN2a disease are eligible)
- Definitive clinical or radiologic evidence of metastatic disease (Note: chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 6 weeks prior to randomization)
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- Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are eligible)
- HER2 test result of IHC 3+, regardless of FISH results, if performed
- Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible)
- History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization
- Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to registration
- Cardiac disease (history of and/or active disease) that would preclude the use of chemotherapy
- Pregnancy or lactation at the time of randomization; (Note: pregnancy testing must be performed within 2 weeks prior to randomization for women of childbearing potential)
- Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
- Use of any investigational product within 30 days prior to registration
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Forsyth Regional Cancer Center
Charlotte, North Carolina, 28204
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Methodist Cancer Center
Houston, Texas, 77030
Lynchburg Hematology Oncology Clinic, Inc
Lynchburg, Virginia, 24501
Virginia Commonwealth University
Richmond, Virginia, 23298
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
Canada1 site
Centre Hospitalier de l'Université de Montréal , Hôtel-Dieu Hospital
Montreal, Quebec, H2W 1T8
About this study
Official title: Choosing Neoadjuvant Chemotherapy Versus Hormonal Therapy for Breast Cancer Based on Gene Expression Profile
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with hormone responsive cancers that were not suitable for breast conserving surgery. The RS is currently used to predict the risk of distant recurrence and the benefit of the addition of chemotherapy to hormonal therapy in the adjuvant setting.
Read the detailed description
Assessed the feasibility of carrying out a large-scale multi-center trial in which recurrence score (RS) was used to select treatment type in the neoadjuvant setting. Whether patients with intermediate RS were willing to be randomized between hormonal and chemotherapy.
The treatment received was not experimental and considered standard treatment for the type of cancer the participants had. What was experimental included the way in which they were assigned to a type of treatment. The design of this study was used to help determine if RS can be used to predict which type of treatment women with breast cancer are most likely to benefit from.
OUTLINE: Patients are assigned to 1 of 3 groups based on RS following Oncotype Dx gene expression profiling.
- GROUP 1 (RS < 11): Patients receive neoadjuvant hormonal therapy comprising tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
- GROUP 2 (RS 11-25): Patients are randomized to 1 of 2 treatment arms:
- ARM 1: Patients receive neoadjuvant hormonal therapy as in group I.
- ARM 2: Patients receive 6-8 courses of neoadjuvant chemotherapy comprising an anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
- GROUP 3 (RS > 25): Patients receive neoadjuvant chemotherapy as in group 2 arm 2.
All patients undergo surgery and receive hormonal therapy for at least 5 years.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
- Being tested
- Neoadjuvant Therapy, Therapeutic Conventional Surgery, Laboratory Biomarker Analysis, Gene Expression Analysis, Systemic Chemotherapy
- Keywords
- Estrogen Receptor Positive, Progesterone Receptor Positive, HER2/Neu Negative, Breast Cancer
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant TherapyProcedure or surgery
Also called Induction Therapy, Neoadjuvant, Preoperative Therapy
Undergo neoadjuvant therapy
Therapeutic Conventional SurgeryProcedure or surgery
Undergo therapeutic conventional surgery
Laboratory Biomarker AnalysisOther
Also called Correlative studies
Correlative studies
Gene Expression AnalysisGenetic
Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Systemic ChemotherapyDrug
Undergo chemotherapy
Tamoxifen CitrateDrug
Also called Nolvadex, TAM, tamoxifen, TMX
Undergo hormonal therapy
Aromatase Inhibition TherapyDrug
Also called Inhibition therapy, aromatase, Aromatase Inhibition, hormonal therapy
Undergo hormonal therapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (RS < 11) | Experimental | Patients with a Recurrence Score (RS) less than 11 (RS <11) are assigned to Group 1, neoadjuvant hormonal therapy either tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
* Hormonal therapy:
* Tamoxifen Citrate (pre-menopausal women) OR
* Aromatase Inhibition Therapy (post-menopausal women) Receives: Procedure: Neoadjuvant Therapy; Procedure: Therapeutic Conventional Surgery; Other: Laboratory Biomarker Analysis; Genetic: Gene Expression Analysis; Drug: Tamoxifen Citrate; Drug: Aromatase Inhibition Therapy |
| Group 2 Arm 1 (RS 11-25) | Experimental | Patients with an intermediate RS (11-25) assigned to Group 2. Randomized to Arm 1, neoadjuvant hormonal therapy as in Group 1.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
* Hormonal therapy:
* Tamoxifen Citrate (pre-menopausal women) OR
* Aromatase Inhibition Therapy (post-menopausal women) Receives: Procedure: Neoadjuvant Therapy; Procedure: Therapeutic Conventional Surgery; Other: Laboratory Biomarker Analysis; Genetic: Gene Expression Analysis; Drug: Tamoxifen Citrate; Drug: Aromatase Inhibition Therapy |
| Group 2 Arm 2 (RS 11-25) | Experimental | Patients with an intermediate RS(11-25) assigned to Group 2. Randomized to Arm 2, neoadjuvant chemotherapy 6-8 courses of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
* Systemic chemotherapy Receives: Procedure: Neoadjuvant Therapy; Procedure: Therapeutic Conventional Surgery; Other: Laboratory Biomarker Analysis; Genetic: Gene Expression Analysis; Drug: Systemic Chemotherapy |
| Group 3 (RS > 25) | Experimental | Patients with a high RS (> 25) assigned to Group 3, neoadjuvant chemotherapy as in Group 2 Arm 2.
Treatment:
* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
* Systemic chemotherapy Receives: Procedure: Neoadjuvant Therapy; Procedure: Therapeutic Conventional Surgery; Other: Laboratory Biomarker Analysis; Genetic: Gene Expression Analysis; Drug: Systemic Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment
The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Harry D. Bear, MD, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293032
- Sponsor's protocol ID
- MCC-13311
- Other IDs
- NCI-2010-02342, P30CA016059
- Status last verified
- Jun 2016
- First submitted
- 7 Feb 2011
- Last updated
- 12 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choosing Neoadjuvant Chemotherapy Versus Hormonal Therapy for Breast Cancer Based on Gene Expression Profile
- ClinicalTrials.gov ID
- NCT01293032
- Acronym / sponsor ID
- MCC-13311
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
- Keywords
- Estrogen Receptor Positive, Progesterone Receptor Positive, HER2/Neu Negative, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Posted 12 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with hormone responsive cancers that were not suitable for breast conserving surgery. The RS is currently used to predict the risk of distant recurrence and the benefit of the addition of chemotherapy to hormonal therapy in the adjuvant setting.
Detailed description
Assessed the feasibility of carrying out a large-scale multi-center trial in which recurrence score (RS) was used to select treatment type in the neoadjuvant setting. Whether patients with intermediate RS were willing to be randomized between hormonal and chemotherapy.
The treatment received was not experimental and considered standard treatment for the type of cancer the participants had. What was experimental included the way in which they were assigned to a type of treatment. The design of this study was used to help determine if RS can be used to predict which type of treatment women with breast cancer are most likely to benefit from.
OUTLINE: Patients are assigned to 1 of 3 groups based on RS following Oncotype Dx gene expression profiling.
- GROUP 1 (RS < 11): Patients receive neoadjuvant hormonal therapy comprising tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
- GROUP 2 (RS 11-25): Patients are randomized to 1 of 2 treatment arms:
- ARM 1: Patients receive neoadjuvant hormonal therapy as in group I.
- ARM 2: Patients receive 6-8 courses of neoadjuvant chemotherapy comprising an anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
- GROUP 3 (RS > 25): Patients receive neoadjuvant chemotherapy as in group 2 arm 2.
All patients undergo surgery and receive hormonal therapy for at least 5 years.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (RS < 11) | Experimental | Procedure: Neoadjuvant Therapy, Procedure: Therapeutic Conventional Surgery, Other: Laboratory Biomarker Analysis, Genetic: Gene Expression Analysis, Drug: Tamoxifen Citrate, Drug: Aromatase Inhibition TherapyPatients with a Recurrence Score (RS) less than 11 (RS <11) are assigned to Group 1, neoadjuvant hormonal therapy either tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System * Hormonal therapy: * Tamoxifen Citrate (pre-menopausal women) OR * Aromatase Inhibition Therapy (post-menopausal women) |
| Group 2 Arm 1 (RS 11-25) | Experimental | Procedure: Neoadjuvant Therapy, Procedure: Therapeutic Conventional Surgery, Other: Laboratory Biomarker Analysis, Genetic: Gene Expression Analysis, Drug: Tamoxifen Citrate, Drug: Aromatase Inhibition TherapyPatients with an intermediate RS (11-25) assigned to Group 2. Randomized to Arm 1, neoadjuvant hormonal therapy as in Group 1. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System * Hormonal therapy: * Tamoxifen Citrate (pre-menopausal women) OR * Aromatase Inhibition Therapy (post-menopausal women) |
| Group 2 Arm 2 (RS 11-25) | Experimental | Procedure: Neoadjuvant Therapy, Procedure: Therapeutic Conventional Surgery, Other: Laboratory Biomarker Analysis, Genetic: Gene Expression Analysis, Drug: Systemic ChemotherapyPatients with an intermediate RS(11-25) assigned to Group 2. Randomized to Arm 2, neoadjuvant chemotherapy 6-8 courses of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/Oncotype DX Gene Expression Profiling System * Systemic chemotherapy |
| Group 3 (RS > 25) | Experimental | Procedure: Neoadjuvant Therapy, Procedure: Therapeutic Conventional Surgery, Other: Laboratory Biomarker Analysis, Genetic: Gene Expression Analysis, Drug: Systemic ChemotherapyPatients with a high RS (> 25) assigned to Group 3, neoadjuvant chemotherapy as in Group 2 Arm 2. Treatment: * Neoadjuvant therapy * Therapeutic conventional surgery * Laboratory biomarker analysis/Correlative studies * Gene Expression Analysis/Oncotype DX Gene Expression Profiling System * Systemic chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy
- The patient must have signed and dated an institutional review board (IRB) approved consent form that conforms to federal and institutional guidelines
- The patient must be female
- The patient must be greater than or equal to 18 years old
- The patient must have an Eastern Cooperative Oncology Group Score (ECOG) performance status of 0 or 1
Key exclusion criteria (16 listed)
- FNA alone to diagnose the primary tumor
- Excisional biopsy or lumpectomy performed prior to randomization
- Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to registration
- Tumors clinically staged as including inflammatory breast cancer
- Ipsilateral cN2b or cN3 disease (patients with cN1 or cN2a disease are eligible)
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 |
|---|---|---|
| Neoadjuvant TherapyAlso: Induction Therapy, Neoadjuvant, Preoperative TherapyUndergo neoadjuvant therapy | Procedure or surgery | Group 1 (RS < 11), Group 2 Arm 1 (RS 11-25), Group 2 Arm 2 (RS 11-25), Group 3 (RS > 25) |
| Therapeutic Conventional SurgeryUndergo therapeutic conventional surgery | Procedure or surgery | Group 1 (RS < 11), Group 2 Arm 1 (RS 11-25), Group 2 Arm 2 (RS 11-25), Group 3 (RS > 25) |
| Laboratory Biomarker AnalysisAlso: Correlative studiesCorrelative studies | Other | Group 1 (RS < 11), Group 2 Arm 1 (RS 11-25), Group 2 Arm 2 (RS 11-25), Group 3 (RS > 25) |
| Gene Expression AnalysisUndergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS). | Genetic | Group 1 (RS < 11), Group 2 Arm 1 (RS 11-25), Group 2 Arm 2 (RS 11-25), Group 3 (RS > 25) |
| Systemic ChemotherapyUndergo chemotherapy | Drug | Group 2 Arm 2 (RS 11-25), Group 3 (RS > 25) |
| Tamoxifen CitrateAlso: Nolvadex, TAM, tamoxifen, TMXUndergo hormonal therapy | Drug | Group 1 (RS < 11), Group 2 Arm 1 (RS 11-25) |
| Aromatase Inhibition TherapyAlso: Inhibition therapy, aromatase, Aromatase Inhibition, hormonal therapyUndergo hormonal therapy | Drug | Group 1 (RS < 11), Group 2 Arm 1 (RS 11-25) |
Primary outcome
The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment
Time frame: Up to 2 years
The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- VCU Massey Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Harry D. Bear, MD, PhD principal investigator
Virginia Commonwealth University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant Therapy, Therapeutic Conventional Surgery and Laboratory Biomarker Analysis in people with Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, run by Virginia Commonwealth University at 8 sites in 2 countries.
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 15 inclusion and 16 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2016; AzTrials last refreshed its copy on 30 Oct 2026.