Metastatic Breast CancerNCT01111175
Triple Negative Breast Cancer Biomarker Study
An observational study of Metastatic Breast Cancer and Triple Negative Breast Cancer, run by US Oncology Research at 18 sites in United States.
Trial summary
Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are scheduled for medically indicated surgical biopsy or resection of disease will be identified. Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation with NextGen sequencing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, Triple Negative Breast Cancer
- How many people
- 14 participants
- Where
- 18 sitesUnited States
- Study dates
- May 2010to Jun 2013
- 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: Evaluable patients with metastatic or locally advanced TNBC who are scheduled for surgical tumor biopsy or resection
Who may be able to join
- Has metastatic or locally recurrent triple negative breast cancer and is scheduled for medically indicated surgical biopsy or resection of disease
- Will have measurable or evaluable (nonmeasurable) disease per RECIST v 1.1 (see Section 10) present after surgical biopsy/resection. Note: following surgical resection, if the tumor sample is found to be inadequate for comprehensive molecular analysis, the patient will be deemed ineligible and will be replaced.
- Has received at least 1 prior chemotherapeutic regimen for their metastatic or locally recurrent TNBC prior to initiating the molecularly-selected therapy. There is no limit on the prior therapy for TNBC. Note: We strongly recommend holding of on intervening therapy if possible from the time of biopsy to the completion of sequencing so as not to change the cancer under the selective pressure of treatment, so that the sequencing results are reflective of the current cancer.
- Is at least 18 years of age
- Has an expected survival of at least 6 months, as estimated by the treating oncologist
- Has planned surgical resection (indicated for the medical care of the patient) that will yield a minimum fresh/frozen tumor sample of 1 cm x 1 cm x 1 cm (~300 mg) that will be available for molecular profiling analysis.
Show all 9Show fewer
- Is agreeable to having a blood sample (10-20 mL) drawn and analyzed to compare their normal genetic profile to that of their tumor sample
- Has signed the most recent Patient Informed Consent Form
- Has signed a Patient Authorization Form
Who cannot join
- Has breast cancer other than metastatic or locally recurrent TNBC. Note: surgical resection of the recurrent TNBC will render the patient as "no evidence of disease" (NED). NED patients are ineligible and will be replaced.
- Has a history of heart disease, other conditions that would prevent treatment with a standard chemotherapeutic agent
- Has evidence of central nervous system (CNS) involvement that is progressing or that requires radiation, resection or steroid therapy
- Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
- Is a pregnant or nursing woman
- Is unable to comply with requirements of study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Virginia Oncology Associates
Chesapeake, Virginia, 23320
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80220
Virginia Oncology Assocites
Elizabeth City, North Carolina, 27909
Virginia Oncology Associates
Hampton, Virginia, 23666
Texas Oncology-Memorial City
Houston, Texas, 77024
Virginia Oncology Associates
Newport News, Virginia, 23606
Virginia Oncology Associates
Norfolk, Virginia, 23502
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97225
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, 97062
Texas Oncology - Tyler
Tyler, Texas, 75702
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98686
Virginia Oncology Associates
Virginia Beach, Virginia, 23456
Virginia Oncology Associates
Williamsburg, Virginia, 23188
About this study
Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are scheduled for medically indicated surgical biopsy or resection of disease will be identified. Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the analysis to identify and prioritize the mutated targets. Therapeutic options, based on the genetic profile of each patient's tumor, will be discussed and an appropriate molecularly-selected agent will be recommended by the Study Investigator(s) (SI) and treating oncologist as treatment for the patient.
This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who are scheduled for medically indicated surgical biopsy or resection will be enrolled and therapeutic options, based on the genetic profile of each patient's tumor, will be discussed with the patient.
Read more
Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy. A 30% increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate prior therapy will be considered as evidence of clinical benefit from the selected therapy. The secondary endpoints are best response to the molecularly-selected therapy, overall survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC.
The study is designed to demonstrate that the collection and analysis of these tumor samples is feasible.
- Keywords
- Locally recurrent breast cancer
- 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.
Time-to-progression (TTP)
Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy.
Measured: Throughout study, for up to 3 years
Secondary outcomes (3)
Best response
Best response to therapy selected based on genomic analysis will be determined. Response will be evaluated in this study using the international criteria published by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee v1.1.
Measured: To molecularly selected therapy, for up to 3 years
Overall survival
Survival will be measured, from the selected treatment start date to the date of death or the last date the patient was known to be alive.
Measured: Throughout the study, for up to 3 years
Genetic mutation evaluation
Genomic analysis of whole blood and resected tumor will be done
Measured: After surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development, Life Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Joyce A O'Shaughnessy, MD, Principal investigator, US Oncology ResearchDaniel Von Hoff, MD, Principal investigator, Translational Drug DevelopmentJohn Carpten, PhD, Principal investigator, Translational Drug Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111175
- Sponsor's protocol ID
- 09-133
- Status last verified
- Jul 2013
- First submitted
- 22 Apr 2010
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Negative Breast Cancer Biomarker Study
- ClinicalTrials.gov ID
- NCT01111175
- Acronym / sponsor ID
- 09-133
- Keywords
- Locally recurrent breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development, Life Technologies, Inc.
- Study start
- May 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Apr 2010 (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.
Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are scheduled for medically indicated surgical biopsy or resection of disease will be identified. Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the analysis to identify and prioritize the mutated targets. Therapeutic options, based on the genetic profile of each patient's tumor, will be discussed and an appropriate molecularly-selected agent will be recommended by the Study Investigator(s) (SI) and treating oncologist as treatment for the patient.
This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who are scheduled for medically indicated surgical biopsy or resection will be enrolled and therapeutic options, based on the genetic profile of each patient's tumor, will be discussed with the patient.
Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy. A 30% increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate prior therapy will be considered as evidence of clinical benefit from the selected therapy. The secondary endpoints are best response to the molecularly-selected therapy, overall survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC.
The study is designed to demonstrate that the collection and analysis of these tumor samples is feasible.
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
- Evaluable patients with metastatic or locally advanced TNBC who are scheduled for surgical tumor biopsy or resection
Key inclusion criteria (9 listed)
- Has metastatic or locally recurrent triple negative breast cancer and is scheduled for medically indicated surgical biopsy or resection of disease
- Will have measurable or evaluable (nonmeasurable) disease per RECIST v 1.1 (see Section 10) present after surgical biopsy/resection. Note: following surgical resection, if the tumor sample is found to be inadequate for comprehensive molecular analysis, the patient will be deemed ineligible and will be replaced.
- Has received at least 1 prior chemotherapeutic regimen for their metastatic or locally recurrent TNBC prior to initiating the molecularly-selected therapy. There is no limit on the prior therapy for TNBC. Note: We strongly recommend holding of on intervening therapy if possible from the time of biopsy to the completion of sequencing so as not to change the cancer under the selective pressure of treatment, so that the sequencing results are reflective of the current cancer.
- Is at least 18 years of age
- Has an expected survival of at least 6 months, as estimated by the treating oncologist
Key exclusion criteria (6 listed)
- Has breast cancer other than metastatic or locally recurrent TNBC. Note: surgical resection of the recurrent TNBC will render the patient as "no evidence of disease" (NED). NED patients are ineligible and will be replaced.
- Has a history of heart disease, other conditions that would prevent treatment with a standard chemotherapeutic agent
- Has evidence of central nervous system (CNS) involvement that is progressing or that requires radiation, resection or steroid therapy
- Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
- Is a pregnant or nursing woman
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
Time-to-progression (TTP)
Time frame: Throughout study, for up to 3 years
Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy.
3 secondary outcomes
Best response
Time frame: To molecularly selected therapy, for up to 3 years
Overall survival
Time frame: Throughout the study, for up to 3 years
Genetic mutation evaluation
Time frame: After surgical resection
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 23 Jul 2013.
Related trials for Metastatic Breast Cancer
RecruitingPhase 3
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Metastatic Breast Cancer
RecruitingPhase 2
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
Breast Cancer Metastatic, Breast Cancer Stage IV
Not yet recruitingPhase 2
Targeting Aurora A Kinase to Overcome Treatment Resistance in Advanced HR+/HER2+ Breast Cancer
HR+/HER2+ Breast Cancer, Metastatic Breast Cancer
RecruitingPhase 1/2
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Not yet recruitingPhase 2
Study of Trastuzumab Deruxtecan in Combination With Stereotactic Radiosurgery in Patients With HER2-Positive Metastatic Breast Cancer and First Diagnosis of Brain Metastases (HERBRAIN)
Breast Cancer (Advanced/Metastatic)
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.
Joyce A O'Shaughnessy, MD principal investigator
US Oncology Research
Daniel Von Hoff, MD principal investigator
Translational Drug Development
John Carpten, PhD principal investigator
Translational Drug Development
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Triple Negative Breast Cancer, run by US Oncology Research at 18 sites 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 6 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 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
Time-to-progression (TTP) (time frame: Throughout study, for up to 3 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 23 Jul 2013.