Breast Cancer Clinical Trial
Official title:
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer
Verified date | May 2013 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to
compare how well they work in treating patients with stage IV breast cancer that has spread
to the bone.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | September 2013 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of breast carcinoma meeting the following criteria: - Stage IV disease - Bone metastasis-predominant disease, defined as the presence of = 1 bone metastasis with or without nonbone (visceral or soft tissue) disease where the number of bone metastases is at least the number of measurable visceral target lesions - Visceral disease that does not cause a reduction in ECOG performance status allowed - Must meet 1 of the following criteria: - Measurable disease within the past 28 days - Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125 documented by 2 consecutive measurements taken = 14 days apart with the most recent measurement being within the past 42 days - These measurements need not be consecutive, and the prior measurement could have been months to years prior to the current measurement if the marker is considered by the investigator to reflect disease progression - The second serum marker value must be greater than the institution's upper limit of normal and show = a 20% increase over the first measurement - No symptomatic brain or CNS metastases - Prior CNS or brain metastasis allowed provided it was treated with radiotherapy = 8 weeks ago - No pleural or pericardial effusion - Hormone receptor status known - Estrogen receptor- and/or progesterone receptor-positive disease must have progressed on = 1 hormonal therapy in the metastatic setting PATIENT CHARACTERISTICS: - Male or female - Menopausal status not specified - Zubrod performance status 0-2 - QTc < 450 msec by EKG - Ejection fraction = 50% by MUGA or 2-dimensional echocardiogram with no significant abnormalities within the past 12 weeks for patients on trastuzumab - No active infection requiring systemic therapy - No uncontrolled concurrent condition that would preclude the ability to take oral medication, including the following: - Nausea - Vomiting - Diarrhea - Lack of physical integrity of the upper gastrointestinal tract - Malabsorption syndrome - No clinically significant cardiac disease, including the following: - Congestive heart failure - Symptomatic coronary artery disease - Cardiac arrhythmias not well controlled - Myocardial infarction within the past 12 months - No concurrent active malignancy - Prior malignancies allowed provided the patient is currently disease-free - Not pregnant or nursing - Fertile patients must use effective contraception during and for 3 months after completion of study therapy PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior RankL inhibitor therapy - No more than 1 prior cytotoxic chemotherapy for metastatic disease - At least 3 weeks since prior chemotherapy and recovered - At least 1 week since prior radiotherapy to non-CNS disease and recovered - At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g., zoledronate) - At least 7 days since prior and no concurrent antiplatelet agents, including any of the following*: - Anticoagulants (e.g., tirofiban, eptifibatide, ticlopidine) - Aspirin or aspirin-containing combinations - Dipyridamole - Epoprostenol - Clopidogrel - Cilostazol - Abciximab NOTE: *Nonsteroidal anti-inflammatory drugs and medically indicated platelet-inhibiting medication allowed - At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: - HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir) - Select antibiotics (e.g., ciprofloxacin, clarithromycin, doxycycline, enoxacin, isoniazid, telithromycin) - Azole antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole) - Select anesthetics (e.g., ketamine, propofol) - Hypericum perforatum (St. John's wort) - Nefazodone - Nicardipine - Diclofenac - Quinidine - Imatinib mesylate - At least 7 days since prior and no concurrent medications that prolong the QTc interval, including any of the following: - Antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide phosphate, amiodarone, sotalol hydrochloride, ibutilide, dofetilide) - Antipsychotic agents (e.g., chlorpromazine, mesoridazine, thioridazine, pimozide, haloperidol, droperidol) - Select antibiotics (e.g., erythromycin, clarithromycin, sparfloxacin, pentamidine) - Narcotic analgesics (e.g., levomethadyl, methadone, domperidone) - Calcium channel blockers (e.g., bepridil, lidoflazine) - Antimalarial agents (e.g., halofantrine, chloroquine) - Parasympathomimetic agents (e.g., cisapride) - Arsenic trioxide - No other concurrent antineoplastic therapy for breast cancer, including any of the following: - Radiotherapy - Chemotherapy - Immunotherapy - Biologic therapy - Hormonal therapy - Gene therapy - No concurrent grapefruit juice consumption - No concurrent short-acting antacid agents within 2 hours of dasatinib administration - Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed provided patients have been on continuous trastuzumab for = 12 weeks |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio |
United States | Hematology Oncology Associates, PC | Albuquerque | New Mexico |
United States | Lovelace Medical Center - Downtown | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Alaska Regional Hospital Cancer Center | Anchorage | Alaska |
United States | Providence Cancer Center | Anchorage | Alaska |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | Highlands Oncology Group - Springdale | Bentonville | Arkansas |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | East Bay Radiation Oncology Center | Castro Valley | California |
United States | Eden Medical Center | Castro Valley | California |
United States | Valley Medical Oncology Consultants - Castro Valley | Castro Valley | California |
United States | Providence Centralia Hospital | Centralia | Washington |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Genesis Medical Center - West Campus | Davenport | Iowa |
United States | Genesis Regional Cancer Center at Genesis Medical Center | Davenport | Iowa |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Cancer Care Center of Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | St. Francis Hospital | Federal Way | Washington |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Valley Medical Oncology | Fremont | California |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Big Sky Oncology | Great Falls | Montana |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Northern Montana Hospital | Havre | Montana |
United States | St. Peter's Hospital | Helena | Montana |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Contra Costa Regional Medical Center | Martinez | California |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville | California |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Providence Cancer Center at Providence Hospital | Mobile | Alabama |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | El Camino Hospital Cancer Center | Mountain View | California |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia |
United States | Alta Bates Summit Medical Center - Summit Campus | Oakland | California |
United States | Bay Area Breast Surgeons, Incorporated | Oakland | California |
United States | CCOP - Bay Area Tumor Institute | Oakland | California |
United States | Highland General Hospital | Oakland | California |
United States | Larry G Strieff MD Medical Corporation | Oakland | California |
United States | Tom K Lee, Incorporated | Oakland | California |
United States | Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington |
United States | Valley Care Medical Center | Pleasanton | California |
United States | Valley Medical Oncology Consultants - Pleasanton | Pleasanton | California |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Good Samaritan Cancer Center | Puyallup | Washington |
United States | Interlakes Oncology/Hematology PC | Rochester | New York |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Salem Hospital Regional Cancer Care Services | Salem | Oregon |
United States | Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas |
United States | Doctors Medical Center - San Pablo Campus | San Pablo | California |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois |
United States | Allenmore Hospital | Tacoma | Washington |
United States | CCOP - Northwest | Tacoma | Washington |
United States | Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington |
United States | MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington |
United States | St. Clare Hospital | Tacoma | Washington |
United States | Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta | Georgia |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival, with disease progression defined as an increase in measurable disease, the appearance of new lesions, and/or clinical deterioration related to disease progression | Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact. | Disease assessed every 8 weeks for up to 2 years until progression. | No |
Secondary | MUC-1 antigen response | MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 = ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression. MUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed. | at 4, 8, 16, and 24 weeks | No |
Secondary | Change in serum bone turnover markers over time | at 4, 8, 16, and 24 weeks | No | |
Secondary | Circulating tumor cell (CTC) response | CTC Response: CTC < 5 cells / 7.5 mL; CTC Non-Response: CTC = 5 cells / 7.5 mL; CTC Inadequate Assessment, response: CTC not able to be evaluated. | at 4, 8, 16, and 24 weeks | No |
Secondary | Toxicity | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Patients assessed at least every eight weeks while on protocol treatment, for up to 2 years | Yes |
Secondary | Response rate (complete and partial, confirmed and unconfirmed) | Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. | Patients assessed at least every eight weeks while on protocol treatment, for up to 2 years | No |
Secondary | Change in patient-reported pain | "worst pain" score from the Brief Pain Inventory Short Form | baseline and 24 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |