Breast CancerPhase 2NCT02067416
PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer
A Phase 2 study testing Anthracycline based chemotherapy and taxane-based chemotherapy in people with Breast Cancer, run by Jenny C. Chang, MD at 1 site in United States.
Trial summary
Study of the assay, Mammostrat®. to verify its utility as a predictor or outcome tool to determine whom would benefit from chemotherapy prior to surgery. Also could be used as a clinical marker to identify patients with breast cancer who do not benefit from some preoperative chemotherapies. 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?
- Anthracycline based chemotherapy and taxane-based chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2014
- Phase
- Phase 2
- 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
Who may be able to join
- Patients with histologic confirmation of invasive breast carcinoma.
- Patients must have intact primary tumor.
- ≥18 years of age.
- Patients with bilateral breast cancer are eligible.
- Patients with second primary breast cancers are eligible.
- The primary breast tumor must be ≥ 2 cm by physical exam or imaging.
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- The tumor must have been determined to be HER2-negative as follows:
- Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to CEP17 must be < 2.2)
- Immunohistochemistry (IHC) 0-1+; or
- IHC 2+ and FISH-negative
- ECOG PS of 0, 1, or 2.
- Negative serum pregnancy test ≤7 days of treatment initiation and a serum or urine pregnancy test must be repeated ≤ 3 days prior to starting treatment for women of childbearing potential (WOCBP). For WOCBP, adequate contraception must be used throughout the study. For this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. Women who are already on hormonal forms of birth control may continue that treatment but must also use a barrier method.
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
- Patient must be willing to undergo breast biopsies as required by the study protocol.
- Sufficient tissue must be available from the diagnostic core biopsies. If not, patients must undergo additional biopsies to perform Mammostrat.
Who cannot join
- Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
- Prior treatment with any investigational drug within the preceding 4 weeks.
- Evidence of New York Heart Association class III or greater cardiac disease.
- History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart Failure or major surgery) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
- Pregnant or nursing women.
- Known allergic reaction to Cremophor or any of the chemo agents on this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study To Validate The Predictive Value Of Mammostrat Score, DDR Score And TLE3 Gene When A Taxane-Based Chemo Agents Or Anthracycline-Based Chemo Agent Is Used In The Neo-Adjuvant Setting
Study of the assay, Mammostrat®. to verify its utility as a predictor or outcome tool to determine whom would benefit from chemotherapy prior to surgery. Also could be used as a clinical marker to identify patients with breast cancer who do not benefit from some preoperative chemotherapies.
Read the detailed description
The purpose of this phase II study is to find out if the test, Mammostrat® can be used as a predictor or outcome tool to determine who will best benefit from chemotherapy prior to surgery. This can be used to determine if Mammostrat assay may be used as a clinical marker to identify a subset of women with breast cancer who do not benefit from preoperative chemotherapy, either taxane/taxane-like (T) chemo agents or anthracycline-based chemotherapy and cyclophosphamide (AC).
- Conditions
- Breast Cancer
- Being tested
- Anthracycline based chemotherapy, taxane-based chemotherapy
- Keywords
- neoadjuvant, mammostrat, TLE3, DDR, 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.
Anthracycline based chemotherapyDrug
Also called Adriamycin, Epirubicin
standard of care neoadjuvant treatment with anthracycline based chemotherapy
taxane-based chemotherapyDrug
Also called Paclitaxel, Docetaxel, Abraxane, Ixabepilone
neoadjuvant taxane based chemotherapy given as standard of care
| Study group | Role | What they receive |
|---|---|---|
| taxane-based chemotherapy | Active comparator | physician choice: taxane-based chemotherapy to include Paclitaxel, Docetaxel, Abraxane or Ixabepilone given as standard of care Receives: Drug: taxane-based chemotherapy |
| anthacycline based chemotherapy | Active comparator | Physician choice: anthracycline based chemotherapy including Adriamycin, Epirubicin give as standard of care Receives: Drug: Anthracycline based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Mammostrat score clinical response rates to chemotherapy
The percentage of patients undergoing chemotherapy who have Mammostrat low risk scores will be calculated
Measured: 2 years
Secondary outcomes (1)
pathological complete response rate compare to predictors
The percentage of patients undergoing chemotherapy who have Mammostrat low risk scores will be calculated
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 posted20 Feb 2014 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Funding agent withdrew funding
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny C. Chang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, Jenny C. Chang, MD, The Methodist Hospital Research Institute
- Investigators
- Angel A Rodriguez, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067416
- Sponsor's protocol ID
- Pro00007624
- Other IDs
- 0712-0127
- Status last verified
- Jan 2023
- First submitted
- 17 Feb 2014
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study To Validate The Predictive Value Of Mammostrat Score, DDR Score And TLE3 Gene When A Taxane-Based Chemo Agents Or Anthracycline-Based Chemo Agent Is Used In The Neo-Adjuvant Setting
- ClinicalTrials.gov ID
- NCT02067416
- Acronym / sponsor ID
- Pro00007624
- Conditions
- Breast Cancer
- Keywords
- neoadjuvant, mammostrat, TLE3, DDR, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding agent withdrew funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jenny C. Chang, MDUniversity, hospital or other
- Collaborators
- GE Healthcare, The Methodist Hospital Research Institute
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Feb 2014 (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.
Study of the assay, Mammostrat®. to verify its utility as a predictor or outcome tool to determine whom would benefit from chemotherapy prior to surgery. Also could be used as a clinical marker to identify patients with breast cancer who do not benefit from some preoperative chemotherapies.
Detailed description
The purpose of this phase II study is to find out if the test, Mammostrat® can be used as a predictor or outcome tool to determine who will best benefit from chemotherapy prior to surgery. This can be used to determine if Mammostrat assay may be used as a clinical marker to identify a subset of women with breast cancer who do not benefit from preoperative chemotherapy, either taxane/taxane-like (T) chemo agents or anthracycline-based chemotherapy and cyclophosphamide (AC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taxane-based chemotherapy | Active comparator | Drug: taxane-based chemotherapyphysician choice: taxane-based chemotherapy to include Paclitaxel, Docetaxel, Abraxane or Ixabepilone given as standard of care |
| anthacycline based chemotherapy | Active comparator | Drug: Anthracycline based chemotherapyPhysician choice: anthracycline based chemotherapy including Adriamycin, Epirubicin give as standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histologic confirmation of invasive breast carcinoma.
- Patients must have intact primary tumor.
- ≥18 years of age.
- Patients with bilateral breast cancer are eligible.
- Patients with second primary breast cancers are eligible.
Key exclusion criteria (7 listed)
- Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.
- Prior treatment with any investigational drug within the preceding 4 weeks.
- Evidence of New York Heart Association class III or greater cardiac disease.
- History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart Failure or major surgery) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
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 |
|---|---|---|
| Anthracycline based chemotherapyAlso: Adriamycin, Epirubicinstandard of care neoadjuvant treatment with anthracycline based chemotherapy | Drug | anthacycline based chemotherapy |
| taxane-based chemotherapyAlso: Paclitaxel, Docetaxel, Abraxane, Ixabepiloneneoadjuvant taxane based chemotherapy given as standard of care | Drug | taxane-based chemotherapy |
Primary outcome
Compare Mammostrat score clinical response rates to chemotherapy
Time frame: 2 years
The percentage of patients undergoing chemotherapy who have Mammostrat low risk scores will be calculated
1 secondary outcome
pathological complete response rate compare to predictors
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Cancer-related options for clinical trial participationLink provided by the sponsor.
- 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.
Angel A Rodriguez, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anthracycline based chemotherapy and taxane-based chemotherapy in people with Breast Cancer, run by Jenny C. Chang, MD 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 15 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: withdrawn, as of the sponsor's last update on 2 Feb 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compare Mammostrat score clinical response rates to chemotherapy (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 2 Feb 2023.