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I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY 2)
This study is currently recruiting participants.
Verified December 2016 by QuantumLeap Healthcare Collaborative
Sponsor:
QuantumLeap Healthcare Collaborative
Information provided by (Responsible Party):
QuantumLeap Healthcare Collaborative
ClinicalTrials.gov Identifier:
NCT01042379
First received: December 31, 2009
Last updated: December 5, 2016
Last verified: December 2016
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Purpose
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
| Condition | Intervention | Phase |
|---|---|---|
| Breast Neoplasms Breast Cancer Breast Tumors | Drug: Standard Therapy Drug: AMG 386 with or without Trastuzumab Drug: AMG 479 (Ganitumab) plus Metformin Drug: MK-2206 with or without Trastuzumab Drug: AMG 386 and Trastuzumab Drug: T-DM1 and Pertuzumab Drug: Pertuzumab and Trastuzumab Drug: Ganetespib Drug: ABT-888 Drug: Neratinib Drug: PLX3397 Drug: Pembrolizumab Drug: Talazoparib plus Irinotecan Drug: Patritumab and Trastuzumab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) |
Resource links provided by NLM:
Further study details as provided by QuantumLeap Healthcare Collaborative:
Primary Outcome Measures:
- Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. [ Time Frame: Post surgery based on upto 24-week treatment ]
Secondary Outcome Measures:
- Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB). [ Time Frame: Blood and Tissue Collection: Baseline, Post-Randomization, Pre-AC, Pre- and Post-Surgery ]
- To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms. [ Time Frame: Three- and Five-Year Post-surgery Follow-up ]
- To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested. [ Time Frame: Post-Randomization, Pre-AC, Pre-Surgery, Post-Surgery upto One Year during follow-up ]
- MRI Volume [ Time Frame: Four time points during the on-study phase: Baseline, Post-randomization, Pre-AC treatment and Pre-Surgery ]
| Estimated Enrollment: | 1920 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard Therapy
Paclitaxel, Herceptin followed by Doxorubicin and Cyclophosphamide treatment depending on HR/HER-2 status.
|
Drug: Standard Therapy
Paclitaxel: 80 mg/m2 IV during the 12 weekly treatment cycles post randomization; Doxorubicin: 60 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16; Cyclophosphamide: 600 mg/m2 IV after completion of the 12 weekly treatment cycles and prior to surgery for weeks 13-16
Other Name: Paclitaxel (Taxol); Doxorubicin (Adriamycin)
|
|
Experimental: AMG 386 with or without Trastuzumab
Arm is closed.
|
Drug: AMG 386 with or without Trastuzumab
Arm is closed.
Other Name: AMG 386 (Trebananib); (Trastuzumab) Herceptin
Drug: AMG 386 and Trastuzumab
Arm is closed.
Other Name: AMG 386 (Trebananib); Trastuzumab (Herceptin)
|
|
AMG 479 plus Metformin
Arm is closed.
|
Drug: AMG 479 (Ganitumab) plus Metformin
Arm is closed.
Other Name: Ganitumab
|
|
Experimental: MK-2206 with or without Trastuzumab
Arm is closed.
|
Drug: MK-2206 with or without Trastuzumab
Arm is closed.
Other Name: (Trastuzumab) Herceptin
|
|
Experimental: T-DM1 and Pertuzumab
Arm is closed.
|
Drug: T-DM1 and Pertuzumab
Arm is closed.
Other Name: T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta)
|
|
Experimental: Pertuzumab and Trastuzumab
Novel Investigational Agent
|
Drug: Pertuzumab and Trastuzumab
Pertuzumab: 840 mg IV (loading dose) week 1 and 420 mg every 3 weeks (weeks 4, 7, 10) post-randomization; Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization
Other Name: Pertuzumab (Perjeta); Trastuzumab (Herceptin)
|
|
Experimental: Ganetespib
Arm is closed.
|
Drug: Ganetespib
Arm is closed.
|
|
ABT-888
Arm is closed.
|
Drug: ABT-888
Arm is closed.
Other Name: Veliparib
|
|
Neratinib
Arm is closed.
|
Drug: Neratinib
Arm is closed.
|
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Experimental: PLX3397
Arm is closed.
|
Drug: PLX3397
Arm is closed.
|
|
Experimental: Pembrolizumab
Novel Investigational Agent
|
Drug: Pembrolizumab
200 mg, IV combined with paclitaxel, given every three weeks (cycles 1, 4, 7, and 10).
|
|
Experimental: Talazoparib plus Irinotecan
Novel Investigational Agent
|
Drug: Talazoparib plus Irinotecan
1000 mg per day, given once daily in capsule form (for 12 weeks continuously) Irinotecan, 25 mg/m2 IV administered cycles 1,3,5,7,9,11
|
|
Experimental: Patritumab with or without Trastuzumab
Novel Investigational Agent
|
Drug: Patritumab and Trastuzumab
Patritumab: 18 mg/kg loading of patritumab (week 1) followed by 9 mg/kg thereafter (weeks 4, 7, 10) post-randomization; Trastuzumab: 4 mg/kg (loading dose) week 1 and 2 mg/kg weekly (weeks 2-12) post-randomization
|
Detailed Description:
I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show a high Bayesian predictive probability of being more effective than standard therapy will graduate from the trial with their corresponding biomarker signature(s). Regimens will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed invasive cancer of the breast
- Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
- No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
- Age ≥18 years
- ECOG performance status 0-1
- Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
- Non-pregnant and non-lactating
- No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
- Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
- Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis
- Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F
- Normal organ and marrow function: Leukocytes ≥ 3000/μL, Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 100,000/μL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)/ALT (SGPT) ≤ 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN
- No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%
- No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase
- Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive by any one of the three methods used (IHC, FISH, TargetPrint™)
- Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)
Exclusion Criteria:
- Use of any other investigational agents within 30 days of starting study treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042379
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042379
Contacts
| Contact: Ruby Singhrao, MS, CCRP | 415-353-4171 | ruby.singhrao@ucsf.edu | |
| Contact: Smita Asare | smita.asare@ispy2.org |
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Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Valerie Caterinicchia, RN, BSN 205-934-5367 val7@uab.edu | |
| Principal Investigator: Andres Forero, MD | |
| United States, Arizona | |
| Mayo Clinic - Scottsdale | Active, not recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| University of Arizona | Active, not recruiting |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| University of California San Diego | Recruiting |
| La Jolla, California, United States, 92093-0698 | |
| Contact: Michael Krak 858-534-5532 mkrak@ucsd.edu | |
| Contact 858-822-5354 CancerCTO@ucsd.edu | |
| Principal Investigator: Anne Wallace, MD | |
| University of Southern California | Active, not recruiting |
| Los Angeles, California, United States, 90033 | |
| University of California San Francisco (UCSF) | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact 877-827-3222 | |
| Principal Investigator: Amy Jo Chien, MD | |
| United States, Colorado | |
| University of Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Tessa Mcspadden 720-848-0609 tessa.mcspadden@ucdenver.edu | |
| Principal Investigator: Anthony Elias, MD | |
| United States, District of Columbia | |
| Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Minetta Liu, MD 202-444-3677 Liumc@georgetown.edu | |
| Principal Investigator: Claudine Isaacs, MD | |
| United States, Florida | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Katrina Dawson, BS, CCRP 813-745-5975 katrina.dawson@moffitt.org | |
| Principal Investigator: Susan Minton, MD | |
| United States, Georgia | |
| Emory University | Active, not recruiting |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60453 | |
| Contact: Simona Olberkyte 773-834-9774 solberkyte@medicine.bsd.uchicago.edu | |
| Principal Investigator: Rita Nanda, MD | |
| Loyola University | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Kathy Czaplicki 708-327-3322 kczapli@lumc.edu | |
| Principal Investigator: Kathy Albain, MD | |
| United States, Kansas | |
| University of Kansas | Active, not recruiting |
| Westwood, Kansas, United States, 66205 | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Anne Janisch, RN MSN 612-626-5369 janis020@umn.edu | |
| Principal Investigator: Doug Yee, MD | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact 507-538-7623 | |
| Principal Investigator: Judy C Boughey, MD | |
| United States, Oregon | |
| Oregon Health & Science Institute (OHSU) | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Jenna Bucher, BS 503-418-9736 bucherj@ohsu.edu | |
| Principal Investigator: Kathleen Y Kemmer, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania (U Penn) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Lauren Bayne 215-349-5398 Lauren.Bayne@uphs.upenn.edu | |
| Principal Investigator: Amy Clark, MD | |
| United States, Texas | |
| University of Texas, Southwestern Medical Center | Active, not recruiting |
| Dallas, Texas, United States, 75390-9155 | |
| University of Texas, M.D. Anderson Cancer Center | Active, not recruiting |
| Houston, Texas, United States, 77230-1439 | |
| United States, Virginia | |
| Inova Health System | Active, not recruiting |
| Falls Church, Virginia, United States, 22042 | |
| United States, Washington | |
| Swedish Cancer Institute | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Hannah Thomas, MSHS 206-386-6911 Hannah.Thomas@Swedish.org | |
| Principal Investigator: Erin Ellis, MD | |
| University of Washington | Active, not recruiting |
| Seattle, Washington, United States, 98115 | |
| Canada, British Columbia | |
| BC Cancer Agency Vancouver Centre | Not yet recruiting |
| Vancouver, British Columbia, Canada, V5Z 1H5 | |
| Contact: Carleen Yu 6048776000 ext 672406 cyu@bccancer.bc.ca | |
| Principal Investigator: Stephen Chia, MD | |
Sponsors and Collaborators
QuantumLeap Healthcare Collaborative
Investigators
| Principal Investigator: | Laura Esserman, MD, MBA | University of California, San Francisco (UCSF) |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | QuantumLeap Healthcare Collaborative |
| ClinicalTrials.gov Identifier: | NCT01042379 History of Changes |
| Other Study ID Numbers: |
097517 |
| Study First Received: | December 31, 2009 |
| Last Updated: | December 5, 2016 |
Keywords provided by QuantumLeap Healthcare Collaborative:
|
I-SPY 2 Neoadjuvant Breast Cancer Neoplasm |
Adaptive pCR Pathologic Complete Response Biomarkers signature MRI Volume |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Irinotecan Ado-trastuzumab emtansine Liposomal doxorubicin Pembrolizumab Pertuzumab Veliparib Trebananib Talazoparib Albumin-Bound Paclitaxel |
Doxorubicin Trastuzumab Metformin Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on July 14, 2017