Breast CancerPhase 2NCT00780676
Personalized Treatment Selection for Metastatic Breast Cancer
A Phase 2 study testing Dasatinib and AZD6244 in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if researchers can use genetic tests to predict who may benefit from treatment with SprycelTM (dasatinib) or selumetinib (AZD6244). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dasatinib and AZD6244
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2014
- Phase
- Phase 2
- 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
- (Turnstile One - Applies only to inclusion criteria 1 - 4): Histologically confirmed breast cancer and evidence of metastatic disease that can be biopsied with acceptable risk. Patients must agree to mandatory fine needle aspiration of the cancer for response marker determination. Patient must have a positive gene expression profile. Positive gene expression signature obtained separately on trial LAB11-0337 will also be acceptable for eligibility.
- Patients must have measurable or evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Subject, age > 18 years (the safety and efficacy of dasatinib and the appropriate dose has not been established for children).
- Signed written informed consent including a HIPAA form according to institutional guidelines.
- (Turnstile Two Applies Only to Inclusion Criteria 5 -17) - Therapy with Dasatinib - Patient must have a positive gene expression profile. Positive gene expression obtained separately on trial LAB11-0337 will also be acceptable for eligibility.
- Performance status Zubrod scale 0-2 (Appendix B) within 8 days of starting therapy.
Show all 17Show fewer
- Full physical examination and history including documentation of weight, height, and vital signs within 8 days of starting therapy.
- Patients may have received any number of previous therapies for metastatic breast cancer. Patients must have received, had a contraindication to, or declined treatment with an anthracycline and taxane (and Herceptin if HER-2 positive) in either the adjuvant or metastatic setting.
- Adequate organ function assessed within 14 days of study therapy, defined as: (a)Total bilirubin </= 2.0 times the institutional Upper Limit of Normal (ULN); (b) Hepatic enzymes (AST, ALT ) </= 2.5 times the institutional ULN; (c) Serum Na, K+, Mg2+, Phosphate and Ca2+ >/= lower limit of normal (LLN); (d) Serum Creatinine < 1.5 time the institutional ULN; and (e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0-1.
- A baseline EKG within 14 days of starting therapy, with a QTc interval not > 460 msec in women, or > 450 in men.
- Ability to take oral medication (dasatinib must be swallowed whole).
- Patient must agree to discontinue St. Johns Wort while receiving dasatinib therapy if previously taken.
- Patient must agree that IV bisphosphonate therapy will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia. (After the need for Ca2+ supplementation has been assessed and levels documented to be >LLN, subjects on prior bisphosphonate may be restarted with caution at the investigator's discretion).
- Females of childbearing potential must have a negative serum pregnancy test within 7 days of starting therapy.
- Persons of reproductive potential must agree to use and utilize a barrier method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.
- Concurrent medications must be assessed, and patient must agree to discontinue all restricted medications within 7 days of starting therapy.
- Stable brain metastasis for at least 3 months
Who cannot join
- (Only turnstile II applies to Exclusion Criteria): Known allergy to study drug.
- Concurrent medical condition which may increase the risk of toxicity, including: (a) pleural or pericardial effusion of any grade; (b) uncontrolled angina, congestive heart failure or MI within (6 months); (c) history of congenital long QT syndrome or prolonged QTc interval on pre-entry electrocardiogram > 460 msec in women and >450 msec. in men; (d) any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); continued in excl # 3
- Continued from exclusion # 2: (e) subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration; (f) history of significant bleeding disorder unrelated to cancer, including diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) or acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies); (g) ongoing or recent (3 months) significant gastrointestinal bleeding
- Concomitant medications with any of the following drugs should be considered for exclusion unless discontinued 7 days prior to starting dasatinib: (a) Category I drugs that prolong QT interval and are generally accepted to have a risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, and domperidone. Cont. in exclusion # 5
- Continued from exclusion criterion # 4: halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
- CYP3A4 inhibitors. Dasatinib is primarily metabolized by the CYP3A4 enzyme. Therefore, potent inhibitors of CYP3A4 may increase dasatinib plasma concentrations: (i) ketoconazole, itraconazole, erythromycin, clarithromycin,ritonavir, atazanavir, indinavir, nefazodone, nelfinavir, saquinavir; (ii) telithromycin; and (iii) subjects should be advised not to consume substantial quantities of grapefruit juice.
Show all 10Show fewer
- Medications which durably inhibit platelet function or inhibit anticoagulation. Medications which directly and durably inhibit platelet function or coagulation include: (i) aspirin or aspirin-containing combinations, clopidogrel, dipyridamole, tirofiban, dipyridamole, epoprostenol, eptifibatide, cilostazol, abciximab, ticlopidine, cilostazol; and (ii) warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]. Exceptions: low-dose warfarin for prophylaxis to prevent catheter thrombosis, and heparin for flushes of IV lines is allowed.
- Women who are unwilling or unable to use a barrier method of contraception to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breast-feeding. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.
- Exclusion from Selumetinib therapy include Uncontrolled hypertension (BP >/=150/95 mmHg), Heart failure (NYHA >/= Class II), prior or current cardiomyopathy (LVEF </= 50%), Atrial fibrillation (heart rate >100 bpm), Unstable ischaemic heart disease (MI within 6 months prior, or angina requiring use of nitrates more than once weekly).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical research study is to learn if researchers can use genetic tests to predict who may benefit from treatment with SprycelTM (dasatinib) or selumetinib (AZD6244).
Read the detailed description
The Study Drug:
Dasatinib blocks several different enzymes called protein kinases that are found in cancer cells. These enzymes are important to cancer cell growth. Blocking these kinases may stop or slow cancer growth.
AZD6244 is designed to block the growth of cancer cells by interfering with specific targeted molecules needed for tumor growth, rather than by simply interfering with rapidly dividing cells (like in traditional chemotherapy).
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take either dasatinib or AZD6244. The drug you take will be decided by your doctor based on the findings of the tumor biopsy.
- If you take dasatinib, you will take 2 dasatinib tablets by mouth once every day. The dasatinib tablets will need to be swallowed whole and can be taken with or without a meal.
- If you take AZD6244, you will take 3 tablets by mouth twice every day. The AZD6244 tablet will need to be taken with 8 ounces of water on an empty stomach (1 hour before or 2 hours after a meal) about 12 hours apart.
If you have side effects, the study doctor may decrease your dose or you may stop receiving the study drug for up to 21 days.
While you receive treatment with dasatinib or AZD6244, you may not receive other anti-cancer treatment such as chemotherapy or hormonal therapy.
If you are receiving treatment with a bisphosphonate that is given by vein (such as Aredia or Zometa), you will not be able to receive the drug during the first 8 weeks of this study. This is done in order to avoid low calcium levels in the blood. You may be able to continue to receive the study drug after the first 8 weeks.
Study Visits:
Every 4 weeks while on study, you will have a complete physical exam. Blood (about 3-4 teaspoons) will be drawn for routine tests.
- If you are taking dasatinib, at Week 4, you will have an ECG.
- If you are taking AZD6244, at Week 8, and experience heart-related side effects suggestive of cardiac problems, you will have an ECHO or multiple gated acquisition scan (MUGA).
Every 8 weeks, the scans (such as MRIs, CTs, and bone scans) and x-rays that were performed at screening will be repeated.
If you experience visual disturbances while receiving AZD6244, you will have an eye exam.
Length of Study:
You may continue taking the study drug daily for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.
End-of-Study Visit:
If you are taken off study because of side effects, you will have CT scans or x-rays to check the status of the disease.
This is an investigational study. Dasatinib is FDA approved to treat chronic myeloid leukemia. It is not yet FDA approved for the treatment of patients with breast cancer. At this time, the use of dasatinib in breast cancer patients is investigational. AZD6244 is not FDA approved or commercially available. Its use in this study is investigational.
The tests that will be used to find out if you can receive treatment with dasatinib or AZD6244 are also investigational.
Up to 769 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Dasatinib, AZD6244
- Keywords
- Dasatinib, Metastatic Breast Cancer, Sprycel, BMS-354825, Genetic testing, AZD6244, Selumetinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel, BMS-354825
100 mg tablet by mouth daily
AZD6244Drug
Also called Selumetinib
75 mg by mouth twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib sensitivity signature | Experimental | Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily. Receives: Drug: Dasatinib |
| SRC pathway activity signature | Experimental | Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily. Receives: Drug: Dasatinib |
| Dasatinib target index | Experimental | Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily. Receives: Drug: Dasatinib |
| Selumetinib pathway predictor | Experimental | Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID). Receives: Drug: AZD6244 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)
Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.
Measured: Tumor status assessed every 8 weeks during therapy, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startJun 2009
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Closed early for futility.
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Stacy Moulder, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780676
- Sponsor's protocol ID
- 2007-0574
- Other IDs
- NCI-2012-01671
- Status last verified
- Sep 2020
- First submitted
- 24 Oct 2008
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Treatment Selection for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00780676
- Acronym / sponsor ID
- 2007-0574
- Conditions
- Breast Cancer
- Keywords
- Dasatinib, Metastatic Breast Cancer, Sprycel, BMS-354825, Genetic testing, AZD6244, Selumetinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early for futility.
- Enrolment
- 97 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, AstraZeneca
- Study start
- Jun 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Oct 2008 (estimated)
- Results
- Posted 20 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if researchers can use genetic tests to predict who may benefit from treatment with SprycelTM (dasatinib) or selumetinib (AZD6244).
Detailed description
The Study Drug:
Dasatinib blocks several different enzymes called protein kinases that are found in cancer cells. These enzymes are important to cancer cell growth. Blocking these kinases may stop or slow cancer growth.
AZD6244 is designed to block the growth of cancer cells by interfering with specific targeted molecules needed for tumor growth, rather than by simply interfering with rapidly dividing cells (like in traditional chemotherapy).
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take either dasatinib or AZD6244. The drug you take will be decided by your doctor based on the findings of the tumor biopsy.
- If you take dasatinib, you will take 2 dasatinib tablets by mouth once every day. The dasatinib tablets will need to be swallowed whole and can be taken with or without a meal.
- If you take AZD6244, you will take 3 tablets by mouth twice every day. The AZD6244 tablet will need to be taken with 8 ounces of water on an empty stomach (1 hour before or 2 hours after a meal) about 12 hours apart.
If you have side effects, the study doctor may decrease your dose or you may stop receiving the study drug for up to 21 days.
While you receive treatment with dasatinib or AZD6244, you may not receive other anti-cancer treatment such as chemotherapy or hormonal therapy.
If you are receiving treatment with a bisphosphonate that is given by vein (such as Aredia or Zometa), you will not be able to receive the drug during the first 8 weeks of this study. This is done in order to avoid low calcium levels in the blood. You may be able to continue to receive the study drug after the first 8 weeks.
Study Visits:
Every 4 weeks while on study, you will have a complete physical exam. Blood (about 3-4 teaspoons) will be drawn for routine tests.
- If you are taking dasatinib, at Week 4, you will have an ECG.
- If you are taking AZD6244, at Week 8, and experience heart-related side effects suggestive of cardiac problems, you will have an ECHO or multiple gated acquisition scan (MUGA).
Every 8 weeks, the scans (such as MRIs, CTs, and bone scans) and x-rays that were performed at screening will be repeated.
If you experience visual disturbances while receiving AZD6244, you will have an eye exam.
Length of Study:
You may continue taking the study drug daily for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.
End-of-Study Visit:
If you are taken off study because of side effects, you will have CT scans or x-rays to check the status of the disease.
This is an investigational study. Dasatinib is FDA approved to treat chronic myeloid leukemia. It is not yet FDA approved for the treatment of patients with breast cancer. At this time, the use of dasatinib in breast cancer patients is investigational. AZD6244 is not FDA approved or commercially available. Its use in this study is investigational.
The tests that will be used to find out if you can receive treatment with dasatinib or AZD6244 are also investigational.
Up to 769 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dasatinib sensitivity signature | Experimental | Drug: DasatinibParticipants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily. |
| SRC pathway activity signature | Experimental | Drug: DasatinibParticipants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily. |
| Dasatinib target index | Experimental | Drug: DasatinibParticipants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily. |
| Selumetinib pathway predictor | Experimental | Drug: AZD6244Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- (Turnstile One - Applies only to inclusion criteria 1 - 4): Histologically confirmed breast cancer and evidence of metastatic disease that can be biopsied with acceptable risk. Patients must agree to mandatory fine needle aspiration of the cancer for response marker determination. Patient must have a positive gene expression profile. Positive gene expression signature obtained separately on trial LAB11-0337 will also be acceptable for eligibility.
- Patients must have measurable or evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Subject, age > 18 years (the safety and efficacy of dasatinib and the appropriate dose has not been established for children).
- Signed written informed consent including a HIPAA form according to institutional guidelines.
- (Turnstile Two Applies Only to Inclusion Criteria 5 -17) - Therapy with Dasatinib - Patient must have a positive gene expression profile. Positive gene expression obtained separately on trial LAB11-0337 will also be acceptable for eligibility.
Key exclusion criteria (10 listed)
- (Only turnstile II applies to Exclusion Criteria): Known allergy to study drug.
- Concurrent medical condition which may increase the risk of toxicity, including: (a) pleural or pericardial effusion of any grade; (b) uncontrolled angina, congestive heart failure or MI within (6 months); (c) history of congenital long QT syndrome or prolonged QTc interval on pre-entry electrocardiogram > 460 msec in women and >450 msec. in men; (d) any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); continued in excl # 3
- Continued from exclusion # 2: (e) subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration; (f) history of significant bleeding disorder unrelated to cancer, including diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) or acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies); (g) ongoing or recent (3 months) significant gastrointestinal bleeding
- Concomitant medications with any of the following drugs should be considered for exclusion unless discontinued 7 days prior to starting dasatinib: (a) Category I drugs that prolong QT interval and are generally accepted to have a risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, and domperidone. Cont. in exclusion # 5
- Continued from exclusion criterion # 4: halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
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 |
|---|---|---|
| DasatinibAlso: Sprycel, BMS-354825100 mg tablet by mouth daily | Drug | Dasatinib sensitivity signature, Dasatinib target index, SRC pathway activity signature |
| AZD6244Also: Selumetinib75 mg by mouth twice daily. | Drug | Selumetinib pathway predictor |
Primary outcome
Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)
Time frame: Tumor status assessed every 8 weeks during therapy, up to 6 months
Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Stacy Moulder, MD principal investigator
UT MD Anderson Cancer Center
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 Dasatinib and AZD6244 in people with Breast Cancer, run by M.D. Anderson Cancer Center 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 17 inclusion and 10 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: stopped early, as of the sponsor's last update on 3 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2015). 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?
Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months) (time frame: Tumor status assessed every 8 weeks during therapy, up to 6 months). 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 3 Sep 2020.