What Quantum Leap Healthcare Collaborative does

Quantum Leap Healthcare Collaborative is a 501(c)(3) charitable nonprofit headquartered in San Francisco, California, that operates the I-SPY family of adaptive platform clinical trials for breast cancer and adjacent indications. Founded in 2007 (originally as the I-SPY Consortium) and rebranded to its current name, the organization has enrolled 2,500+ patients and evaluated 25+ therapeutic agents across a national network of ~50 US-based academic medical centers and community oncology practices. The core platform combines Bayesian adaptive randomization, serial MRI monitoring, molecular biomarker integration (MammaPrint/BluePrint), and response-predictive subtype stratification to enable simultaneous multi-arm evaluation of novel oncology agents, with three agents receiving accelerated FDA approval to date including pembrolizumab in neoadjuvant triple-negative breast cancer (72.6% pCR rate).

The organization's product portfolio spans I-SPY 2, I-SPY 2.2 (launched June 2022), PRE-I-SPY Phase 1 metastatic platform, I-SPY COVID/ARDS, and RECAST DCIS (launched 2026). Underpinning these trials is OneSource Connect, an integrated EHR data capture platform deployed across 25+ sites with Epic and Cerner integration, and OneSource AI, an analytics workspace providing AI/ML-driven predictive modeling over clinical, imaging, biomarker, and sequencing data including 7,000+ H&E image files. Patient-facing infrastructure includes BreastCancerTrials.org (trial matching), Clinical Trial Navigator, Metastatic Trial Search, and Metastatic Trial Talk.

Revenue is generated through sponsored research agreements with 15+ pharmaceutical and biotechnology sponsors (Genentech, Merck, Amgen, Pfizer, AstraZeneca, Eli Lilly, AbbVie, Johnson & Johnson, Arvinas, TransCode, Atossa, Stemline, Menarini, Havah, Zymeworks, SymphGen), supplemented by philanthropic donations from foundations (Avon Foundation, Safeway Foundation, Breast Cancer Research Foundation, J&J Foundation) and individual donors. The go-to-market motion relies on scientific credibility established through peer-reviewed publications in JAMA Oncology and Nature Medicine, presentations at ASCO and SABCS, and direct enterprise business development with pharma R&D teams, rather than conventional product pricing.

Name

Quantum Leap Healthcare Collaborative

Legal name

Quantum Leap Healthcare Collaborative

Website

https://quantumleaphealth.org

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Quantum Leap Healthcare Collaborative is a 501(c)(3) nonprofit operating the I-SPY family of adaptive platform clinical trials for breast cancer and adjacent indications, enrolling 2,500+ patients across ~50 US sites and funded by pharma sponsored research agreements and philanthropic donations.

Ownership category

akta.pro rank

Product category

Adaptive Clinical Trial Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)

akta.pro secondary industries

Precision Clinical Trials Enablement (patient matching, site matching, adaptive trials) (HLAAANAI), AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO), Clinical Decision Support & Workflow Integration (EHR/oncology systems) (HLAAANAE), Oncology Pathways & Precision Medicine Decision Support (HLACAGAH)

Keywords

• Adaptive clinical trials
• Oncology platform trials
• Breast cancer research
• Clinical trial data platform
• Biomarker-driven drug development

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure, Others

Revenue model

1. Pharmaceutical Research Grants and Sponsored Clinical Trials: The primary revenue stream consists of sponsored research agreements and grants from pharmaceutical companies. Pharma partners (e.g., Genentech, Amgen, Pfizer, Merck, AstraZeneca, Eli Lilly, AbbVie, Johnson & Johnson) fund the evaluation of their drug candidates within the adaptive I-SPY platform trials. Revenue is received as upfront fees, milestone payments tied to trial enrollment and completion, and regulatory milestone achievements.
2. Non-Profit Donations and Philanthropic Funding: As a 501(c)(3) nonprofit organization, Quantum Leap Healthcare Collaborative relies on charitable donations from individuals, foundations (e.g., Avon Foundation, Safeway Foundation, Breast Cancer Research Foundation), and corporate giving programs to fund platform infrastructure, patient support programs, and operational costs not covered by pharma agreements.
3. Clinical Trial Matching Services: BreastCancerTrials.org, a subsidiary platform, matches patients to clinical trials including those conducted by Quantum Leap. This platform may generate revenue through pharma-sponsored patient referral arrangements and trial site support services.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

Quantum Leap Healthcare Collaborative operates the I-SPY family of adaptive platform clinical trials for oncology drug development. The organization provides pharmaceutical sponsors with a Bayesian-adaptive trial infrastructure that evaluates multiple investigational agents in parallel for high-risk breast cancer and other cancers, using serial MRI, molecular biomarkers, and the OneSource data and AI platform to accelerate go/no-go decisions.

Product overview

Quantum Leap Healthcare Collaborative operates a platform of adaptive clinical trials for cancer treatment development, centered around the I-SPY family of trials. The core offerings include the I-SPY 2.2 Trial (the latest evolution of the adaptive platform trial for early breast cancer), the original I-SPY 2 Trial, PRE-I-SPY Phase 1 platform, I-SPY COVID/ARDS Trial, and the RECAST DCIS platform trial. Supporting infrastructure includes OneSource Connect (EHR data capture from Epic and Cerner), OneSource AI (data analytics and AI/ML workspace), and patient-facing services like BreastCancerTrials.org (trial matching), Clinical Trial Navigator, Metastatic Trial Search, and Metastatic Trial Talk. The platform employs adaptive trial designs with serial MRI monitoring and response-predictive subtypes to accelerate drug development.

Differentiator

Problem solved

Functional benefit

Products and services

• I-SPY 2 Trial A standing, multicenter, randomized Phase 2 adaptive platform trial designed to evaluate multiple investigational agents in combination with standard neoadjuvant chemotherapy for women with newly diagnosed, high-risk breast cancer. It is intended for pharmaceutical sponsors seeking faster, biomarker-driven go/no-go decisions.
• I-SPY 2.2 Trial The current-generation adaptive platform trial, building on I-SPY 2 with expanded immunotherapy arms, deeper molecular biomarker integration, and refined Bayesian adaptive randomization. Designed for pharmaceutical sponsors seeking to evaluate targeted and immune agents in high-risk breast cancer.
• PRE-I-SPY Phase 1 Trial A Phase 1 component of the I-SPY platform program, preparing and qualifying investigational agents for entry into the adaptive I-SPY 2.2 trial. For pharmaceutical sponsors seeking earlier-stage evaluation ahead of platform randomization.
• RECAST DCIS Trial An adaptive platform trial extension focused on ductal carcinoma in situ (DCIS), applying the I-SPY model of Bayesian-adaptive evaluation to non-invasive early-stage breast disease. Intended for pharmaceutical sponsors working in DCIS and early-lesion therapeutics.
• I-SPY COVID/ARDS Trial An adaptive platform trial applying the I-SPY Bayesian-adaptive design to COVID-19-associated acute respiratory distress syndrome (ARDS). Intended for pharmaceutical sponsors evaluating critical-care therapies in a pandemic setting.
• BreastCancerTrials.org A national patient-facing service that helps breast cancer patients identify and connect with relevant breast cancer clinical trials. Used by patients, family members, and clinicians to drive trial recruitment.
• OneSource Connect A clinical trial data integration and site-connectivity platform that links academic medical centers, sponsors, and study teams within the I-SPY network. Used by participating sites and pharmaceutical sponsors to manage trial operations, data sharing, and reporting.
• OneSource AI An analytics and AI module within the OneSource platform that applies advanced biomarker and outcome analytics across the I-SPY trial portfolio. Used by sponsors and investigators to derive predictive insights from longitudinal clinical, imaging, and molecular data.
• Metastatic Trial Search A search and matching service for metastatic breast cancer patients seeking clinical trial options. Used by patients, caregivers, and clinicians for trial identification.
• Metastatic Trial Talk An educational and discussion service focused on metastatic breast cancer, supporting patients exploring clinical trial options. Used by metastatic breast cancer patients and their support network.
• Clinical Trial Navigator A guided clinical trial enrollment service for breast cancer patients, providing step-by-step navigation through screening, eligibility, and consent. Used by breast cancer patients and families seeking trial enrollment support.

Quantifiable outcome

• 72.6% pathologic complete response (pCR) rate with pembrolizumab + chemotherapy in triple-negative breast cancer, compared to ~40% pCR with chemotherapy alone — enabling accelerated FDA approval
• +4 more outcomes

Named customers16 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability2 records

Feature7 records

Partnerships

16 partnerships are on record, tiered core.

• ArvinascoreStrategic or Co-development PartnerArvinas is collaborating with Quantum Leap Healthcare on the I-SPY-2 End-of-Phase (EOP) clinical study evaluating vepdegestrant (ARV-471), an androgen receptor (AR) degrader, in combination with pembrolizumab for the treatment of early-stage breast cancer. This is a co-development arrangement within the established I-SPY adaptive platform trial infrastructure.
• TransCode TherapeuticscoreStrategic or Co-development PartnerTransCode Therapeutics has partnered with Quantum Leap Healthcare on the PRE-I-SPY platform to evaluate TTX-MC138, a novel oligonucleotide therapeutic targeting microRNA-155, within the I-SPY trial network. TTX-MC138-101 is the first clinical trial under this collaboration, designed to assess efficacy signals in metastatic breast cancer patients.
• Stemline TherapeuticscoreStrategic or Co-development PartnerStemline Therapeutics is participating in the RECAST DCIS trial, evaluating elacestrant (ORSERDU), a selective estrogen receptor degrader (SERD), in patients with ductal carcinoma in situ (DCIS). This collaboration leverages the I-SPY adaptive platform infrastructure to assess novel therapeutic approaches in DCIS.
• Atossa TherapeuticscoreStrategic or Co-development PartnerAtossa Therapeutics is collaborating on the RECAST DCIS trial, evaluating (Z)-endoxifen, a selective estrogen receptor modulator (SERM), in patients with ductal carcinoma in situ (DCIS). The RECAST DCIS platform applies the I-SPY adaptive trial methodology to the DCIS disease setting.
• The Menarini GroupcoreStrategic or Co-development PartnerThe Menarini Group is participating in the RECAST DCIS trial, evaluating elagolix, a GnRH antagonist, in patients with ductal carcinoma in situ (DCIS). This collaboration tests a novel endocrine-targeted approach in DCIS using the RECAST adaptive platform design.
• Havah TherapeuticscoreStrategic or Co-development PartnerHavah Therapeutics is a biotech sponsor participating in the RECAST DCIS trial, evaluating a novel therapeutic candidate in patients with ductal carcinoma in situ (DCIS). This collaboration extends the I-SPY adaptive platform methodology into the DCIS research setting.
• MerckcoreStrategic or Co-development PartnerMerck's Keytruda (pembrolizumab) was evaluated within the I-SPY 2 adaptive platform trial. The trial arm demonstrated a 72.6% pathologic complete response (pCR) rate in triple-negative breast cancer, substantially exceeding historical benchmarks and leading to an accelerated FDA approval for the neoadjuvant TNBC indication.
• GenentechcoreStrategic or Co-development PartnerGenentech has served as a pharma sponsor within the I-SPY 2 adaptive platform trial, having its therapeutic candidates evaluated alongside competing agents in the multi-arm adaptive design. Genentech's participation reflects the platform's value in generating comparative efficacy data across multiple agents simultaneously.
• AmgencoreStrategic or Co-development PartnerAmgen has been a pharma sponsor within the I-SPY 2 adaptive platform trial, evaluating therapeutic candidates in early-stage breast cancer using the platform's serial MRI monitoring and adaptive randomization infrastructure.
• PfizercoreStrategic or Co-development PartnerPfizer has been a pharma sponsor within the I-SPY 2 adaptive platform trial, leveraging the platform's adaptive design and predictive biomarker capabilities to evaluate its therapeutic candidates in early-stage breast cancer.
• AstraZenecacoreStrategic or Co-development PartnerAstraZeneca has been a pharma sponsor within the I-SPY 2 adaptive platform trial, evaluating therapeutic candidates in the multi-arm adaptive design with serial MRI monitoring and molecular biomarker stratification.
• Eli LillycoreStrategic or Co-development PartnerEli Lilly has been a pharma sponsor within the I-SPY 2 adaptive platform trial, using the platform to evaluate its oncology drug candidates in early-stage breast cancer with adaptive randomization and predictive biomarker-driven patient selection.
• AbbViecoreStrategic or Co-development PartnerAbbVie has been a pharma sponsor within the I-SPY 2 adaptive platform trial, evaluating therapeutic candidates in early-stage breast cancer using the platform's adaptive design and comprehensive data collection infrastructure.
• Johnson & JohnsoncoreStrategic or Co-development PartnerJohnson & Johnson has been a pharma sponsor within the I-SPY 2 adaptive platform trial, leveraging the platform's adaptive randomization and serial MRI response monitoring to evaluate its therapeutic candidates in early-stage breast cancer.
• ZymeworkscoreStrategic or Co-development PartnerZymeworks, a clinical-stage biopharmaceutical company, has been a sponsor within the I-SPY 2 adaptive platform trial, evaluating its bispecific antibody candidates in early-stage breast cancer using the platform's adaptive design.
• SymphGencoreStrategic or Co-development PartnerSymphGen, a biotech company, has been a sponsor within the I-SPY 2 adaptive platform trial, leveraging the platform's biomarker-driven patient selection and adaptive randomization to evaluate its novel therapeutic candidates.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Tempus Labs: AI-driven precision medicine company focused on oncology, with multi-modal data (clinical, imaging, molecular) used for trial matching and biomarker-driven research. Comparable to QLHC's OneSource AI as a competing AI-oncology data and analytics layer for sponsors.
• Flatiron Health: Oncology-focused real-world data and EHR-linked clinical trial platform, with AI-driven abstraction and trial matching. Comparable to QLHC's OneSource + BreastCancerTrials.org stack because it sits at the intersection of oncology EHR data, AI analytics and trial enablement.

Direct peers

• SWOG Cancer Research Network: NCI-supported cooperative group that runs platform-style oncology trials (e.g., LUNG-MAP master protocol). It is one of the closest analogues to QLHC's I-SPY adaptive platform model and represents the primary peer in platform-trial design in oncology.
• MRC Clinical Trials Unit at UCL: UK academic clinical trials unit that runs adaptive platform trials (including in critical care) with methodologically rigorous Bayesian and adaptive designs. Directly comparable to QLHC's adaptive platform expertise outside the US.
• NRG Oncology: NCI-supported cooperative group focused on breast, gynecologic, and other cancers, with strong biomarker-driven trial programs. Highly comparable to QLHC given overlapping breast-cancer focus and multi-site trial execution.
• ECOG-ACRIN Cancer Research Group: NCI-funded cooperative oncology group that designs and runs multi-arm, multi-site cancer clinical trials in the US. Highly comparable to QLHC as it executes large, multi-site oncology trials with biomarker integration and shared infrastructure across academic and community sites.
• Alliance for Clinical Trials in Oncology: NCI-funded cooperative oncology group conducting multi-institution clinical trials across academic and community sites. Operates comparable models of large, multi-site oncology trials with biomarker-driven sub-studies.
• European Organisation for Research and Treatment of Cancer (EORTC): European nonprofit that designs and runs multi-center cancer clinical trials, including biomarker-stratified studies. Comparable to QLHC in mission and trial design, with a primarily regional (European) footprint.

Broad incumbents

• Medidata (Dassault Systèmes): Major clinical trial technology platform (Rave EDC, RTSM, synthetic control arm, AI analytics). Comparable to OneSource as enterprise clinical-trial technology infrastructure used by sponsors and sites globally.
• IQVIA: Global CRO with a large oncology clinical operations footprint and proprietary data/analytics assets (e.g., E360, Orchestrated Customer Engagement). Comparable as a broad incumbent in pharma-sponsored oncology trial execution and data infrastructure.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Quantum Leap Healthcare Collaborative