Metastatic Breast CancerMAP-ITNCT01855503
Breast Cancer Molecular Analysis Protocol
An observational study of Metastatic Breast Cancer, run by Yale University at 1 site in United States.
Trial summary
This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Core Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Metastatic Breast Cancer
Who may be able to join
- All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
- Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.
- There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
- Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
- Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.
Who cannot join
- 1. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Smilow Hospital Breast Center
New Haven, Connecticut, 06520-8032
About this study
Official title: Breast Cancer Molecular Analysis Prior to Investigational Therapy
This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Core Biopsy
- Keywords
- Metastatic, Breast Cancer, Metastatic Breast Cancer, Breast, Biopsy, Molecular, Genetic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core BiopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer | Not described Receives: Procedure: Core Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular analysis of metastatic breast cancer using DNA sequencing
The primary goal is to survey the known DNA abnormalities with potential therapeutic relevance in cancer and steer patients to therapies that target the detected abnormalities.
Measured: 2 years
Secondary outcomes (1)
To establish a metastatic breast cancer tissues resource for future research
The secondary objective is to establish a metastatic breast cancer tissues resource for future research to learn about biological events that drive metastatic cancer and to identify novel therapeutic targets and predictors of response to therapy.
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 posted16 May 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2016
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.
- More trials run by Yale 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Medicine
- Responsible party
- Sponsor
- Investigators
- Lajos Pusztai, M.D., D.Phil, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855503
- Sponsor's protocol ID
- HIC# 1210010985
- Acronym
- MAP-IT
- Status last verified
- Nov 2016
- First submitted
- 13 May 2013
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Molecular Analysis Prior to Investigational Therapy
- ClinicalTrials.gov ID
- NCT01855503
- Acronym / sponsor ID
- MAP-IT / HIC# 1210010985
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic, Breast Cancer, Metastatic Breast Cancer, Breast, Biopsy, Molecular, Genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Foundation Medicine
- Study start
- May 2013
- Primary completion
- Aug 2016 (actual)
- First posted
- 16 May 2013 (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 molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer | – | Procedure: Core Biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Metastatic Breast Cancer
Key inclusion criteria (5 listed)
- All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
- Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.
- There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
- Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
- Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.
Key exclusion criteria (1 listed)
- 1. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent
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 |
|---|---|---|
| Core Biopsy | Procedure or surgery | Metastatic Breast Cancer |
Primary outcome
molecular analysis of metastatic breast cancer using DNA sequencing
Time frame: 2 years
The primary goal is to survey the known DNA abnormalities with potential therapeutic relevance in cancer and steer patients to therapies that target the detected abnormalities.
1 secondary outcome
To establish a metastatic breast cancer tissues resource for future research
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 17 Nov 2016.
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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.
Lajos Pusztai, M.D., D.Phil principal investigator
Yale 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 Metastatic Breast Cancer, run by Yale 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 5 inclusion and 1 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 17 Nov 2016. 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?
molecular analysis of metastatic breast cancer using DNA sequencing (time frame: 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 17 Nov 2016.