Trial · NCT01042379
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
NCT01042379, Phase 2, Recruiting, QuantumLeap Healthcare Collaborative
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer. Trials, record NCT01042379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01042379
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
- NCT number
- NCT01042379
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 5,000 participants, estimated
- Lead sponsor
- QuantumLeap Healthcare Collaborative
- Conditions
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
- Interventions
Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin, MK-2206 with or without Trastuzumab, AMG 386 and Trastuzumab, T-DM1 and Pertuzumab, Pertuzumab and Trastuzumab, Ganetespib, ABT-888, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, Amcenestrant + Abemaciclib, Amcenestrant + Letrozole, ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, Datopotamab deruxtecan, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel, GSK 5733584, GSK 5733584 + Dostarlimab, Ivonescimab (20mg/kg Q3W)
- First posted
- 2010-01-05
- Last updated
- 2026-05-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | Post surgery based on upto 36-week treatment | |
| Secondary | Establishing predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB). | Blood and Tissue Collection: Baseline, Post-Randomization, Pre-AC, Pre- and Post-Surgery | |
| Secondary | To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms. | Three- and Five-Year Post-surgery Follow-up | |
| Secondary | To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested. | Post-Randomization, Pre-AC, Pre-Surgery, Post-Surgery upto One Year during follow-up | |
| Secondary | MRI Volume | Four time points during the on-study phase: Baseline, Post-randomization, Pre-AC treatment and Pre-Surgery |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers41
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01042379
GET https://conductscience.org/api/trials/v1/NCT01042379/papers?page=2