Breast CancerNCT01514565
Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer
An observational study of Breast Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a prospective observational study aimed to validate biomarkers that predict response. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2018
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A maximum of 70 eligible patients will be enrolled. Accrual is expected to be completed in 18-24 months. All patients must have histologically confirmed triple negative breast cancer and be eligible to receive neoadjuvant chemotherapy.
Who may be able to join
- Age > 18 years old
- Histologically-confirmed triple negative invasive breast carcinoma
- Any type of ductal or lobular invasive carcinoma
- Patients with or without BRCA-1 and BRCA-2 mutations are eligible to participate
- Life expectancy > 6 months
- Pre-, Peri- or Postmenopausal
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- Clinical Stage T2-4, N0-3, M0 (Stage II-III)
- Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
- Adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. However, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario.
Who cannot join
- Prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM)
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).
- Only ductal/lobular carcinoma in situ but not invasive component
- Any sort of confirmed metastatic disease (AJCC Stage IV at diagnosis)
- Any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy
- Pregnant or lactating, in case this precludes the subject to receive chemotherapy.
- Impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. This will be exclusively decided by the treating oncologists.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Agnieszka Witkiewicz, MD, 215-955-3778, Agnieszka.Witkiewicz@jefferson.edu
Gordon Schwartz, MD, 215-955-6999, Gordon.Schwartz@jefferson.edu
About this study
Official title: Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
This is a prospective observational study aimed to validate biomarkers that predict response.
Read the detailed description
This is a prospective observational cohort study, with no control group and no direct experimental intervention, where the patient's pathological material will be used to examine the expression of molecular biomarkers believed to predict chemotherapy response. Patients with locally advanced triple negative breast cancer, who are candidates for neoadjuvant chemotherapy, will be enrolled in this clinical study. Patients will receive standard of care, FDA-approved and clinically validated chemotherapy regimens. The biopsy specimens taken during the diagnostic phase (pre-treatment specimen) will be used for specific biomarker evaluation. Data obtained from this pre-treatment phase will be compared with the surgical specimens (post-treatment phase) obtained after receiving neoadjuvant chemotherapy. The primary endpoint is to assess the ability of specific biomarkers to predict treatment response, and thus identify those patients who will achieve benefit from such treatment.
- Conditions
- Breast Cancer
- Keywords
- Triple negative Breast Cancer, RB, PTEN, Chemotherapy, Neoadjuvant
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological status of retinoblastoma tumour suppressor (RB)
The primary endpoint is to assess the impact of histological RB-status on pathological complete response (pCR). pCR is a well validated surrogate of chemotherapy sensitivity and allows the identification of a group of patients with excellent prognosis.
Measured: Nine weeks
Secondary outcomes (2)
Correlation of RB and other biomarkers
- Correlation between RB and PTEN tumor suppressor status and other biomarkers with pCR
- Correlation between RB-status, RB and PTEN status and other biomarkers with recurrence free survival (RFS) and overall survival (OS)
Measured: Nine weeks
Determine the utility of an RB molecular test
Gene expression profiling of biopsy specimens to determine utility of an RB molecular test.
Measured: Assessed within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnieszka Witkiewicz, MD, Principal investigator, Thomas Jefferson UniversityGordon Schwartz, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514565
- Sponsor's protocol ID
- 11D-574
- Status last verified
- Mar 2015
- First submitted
- 17 Jan 2012
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Suppressor Status as a Predictor of Chemotherapy Response in Triple Negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT01514565
- Acronym / sponsor ID
- 11D-574
- Conditions
- Breast Cancer
- Keywords
- Triple negative Breast Cancer, RB, PTEN, Chemotherapy, Neoadjuvant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Jan 2012 (estimated)
- 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 is a prospective observational study aimed to validate biomarkers that predict response.
Detailed description
This is a prospective observational cohort study, with no control group and no direct experimental intervention, where the patient's pathological material will be used to examine the expression of molecular biomarkers believed to predict chemotherapy response. Patients with locally advanced triple negative breast cancer, who are candidates for neoadjuvant chemotherapy, will be enrolled in this clinical study. Patients will receive standard of care, FDA-approved and clinically validated chemotherapy regimens. The biopsy specimens taken during the diagnostic phase (pre-treatment specimen) will be used for specific biomarker evaluation. Data obtained from this pre-treatment phase will be compared with the surgical specimens (post-treatment phase) obtained after receiving neoadjuvant chemotherapy. The primary endpoint is to assess the ability of specific biomarkers to predict treatment response, and thus identify those patients who will achieve benefit from such treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A maximum of 70 eligible patients will be enrolled. Accrual is expected to be completed in 18-24 months. All patients must have histologically confirmed triple negative breast cancer and be eligible to receive neoadjuvant chemotherapy.
Key inclusion criteria (9 listed)
- Age > 18 years old
- Histologically-confirmed triple negative invasive breast carcinoma
- Any type of ductal or lobular invasive carcinoma
- Patients with or without BRCA-1 and BRCA-2 mutations are eligible to participate
- Life expectancy > 6 months
Key exclusion criteria (7 listed)
- Prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM)
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician).
- Only ductal/lobular carcinoma in situ but not invasive component
- Any sort of confirmed metastatic disease (AJCC Stage IV at diagnosis)
- Any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histological status of retinoblastoma tumour suppressor (RB)
Time frame: Nine weeks
The primary endpoint is to assess the impact of histological RB-status on pathological complete response (pCR). pCR is a well validated surrogate of chemotherapy sensitivity and allows the identification of a group of patients with excellent prognosis.
2 secondary outcomes
Correlation of RB and other biomarkers
Time frame: Nine weeks
Determine the utility of an RB molecular test
Time frame: Assessed within 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Agnieszka Witkiewicz, MD principal investigator
Thomas Jefferson University
Gordon Schwartz, MD principal investigator
Thomas Jefferson University
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 Thomas Jefferson University 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Witkiewicz, MD (215-955-3778, Agnieszka.Witkiewicz@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological status of retinoblastoma tumour suppressor (RB) (time frame: Nine weeks). 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 18 Mar 2015.