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QUANTUM LEAP HEALTHCARE COLLABORATIVE

SAN FRANCISCO, CA · EIN 204284925 · Form 990 · FY2022 · NTEE P20 · Human Services · Large ($10M-$50M) · www.quantumleaphealth.org
revenue
$47.3M
expenses
$47.2M
net assets
$30.0M
employees
113
volunteers
12
program ratio
94%
mission · from form 990

THE MISSION OF QUANTUM LEAP HEALTHCARE COLLARBORATIVE IS TO PROVIDE (CONTINUED ON SCH. O)MANAGEMENT AND FINANCIAL SUPPORT TO HEALTHCARE RESEARCH ORGANIZATIONS, PARTICULARLY INVOLVING BREAST CANCER RESEARCH AND TREATMENT.

profile · synthesized from sources

Quantum Leap Healthcare Collaborative is an operational research organization that designs and implements adaptive clinical trials, primarily focusing on breast cancer. They collaborate with academic and community cancer centers across the United States to accelerate the development of new treatments for patients.

irs program accomplishments · form 990 part iii · fy2022

what they reported doing

Program narrative the organization filed with the IRS. Ordered by program spending.

  1. #1 primary $20.05M
    DURING FISCAL YEAR 2020, THE I-SPY COVID TRIAL AN ADAPTIVE PLATFORM TRIAL, WAS DESIGNED TO RAPIDLY SCREEN AND CONFIRM HIGH IMPACT TREATMENTS TO REDUCE MORTALITY AND TIME ON VENTILATORS. THIS WORK IS INDEPENDENT AND EQUALLY AS IMPORTANT AS VACCINE EFFORTS. I-SPY COVID TRIAL FOCUSES ON THOSE PATIENTS WHOSE REACTIONS TO THE VIRUS MAKE THEM CRITICALLY ILL AND, IN MANY CASES, RESULTS IN DEATH. THE PRIMARY FOCUS OF THE TRIAL WAS TO IDENTIFY PROMISING DRUGS THAT EITHER NEUTRALIZE THE VIRUS, HELP HEAL THE LUNG DAMAGE FROM THE VIRUS (CAUSED BY ADULT RESPIRATORY DISTRESS SYNDROME OR (ARDS) OR TO CHANGE THE IMMUNE SYSTEM REACTION WHICH RESULTS IN ILLNESS (FOR YOUNGER PEOPLE, THIS IS ESPECIALLY IMPORTANT). THE TRIAL OPENED JUNE 2020 AND WILL CONTINUE TO RUN UNTIL A DRUG OR COMBINATIONS OF DRUGS, IS FOUND THAT PREVENTS THE NECESSITY FOR VENTILATION TREATMENT AND ELIMINATES DEATH FROM THE DISEASE.
  2. #2 $1.21M
    BREAST CANCER TRIALS (BCT) - LAUNCHED IN 2008, FOLLOWING A SUCCESSFUL UCSF-NCI SPONSORED RESEARCH PILOT, ITS MISSION IS TO MAKE PATIENT CONSIDERATION OF TRIALS THE NORM VS. THE EXCEPTION. WE BELIEVE THAT ALL PATIENTS SHOULD HAVE ACCESS TO THE LATEST MEDICAL KNOWLEDGE ABOUT BREAST CANCER TREATMENT AS WELL AS THE OPPORTUNITY TO ADVANCE BREAST CANCER RESEARCH. BCT LISTS OVER 600 STUDIES FOR PEOPLE WITH NEWLY DIAGNOSED BREAST CANCER, METASTATIC DISEASE, OR POST-TREATMENT SURVIVORS. IT INCLUDES INNOVATIVE TRIALS OF TARGETED AND IMMUNOTHERAPIES AS WELL AS OBSERVATIONAL STUDIES LOOKING AT QUALITY OF LIFE, GENETIC MUTATIONS, AND BREAST CANCER SURVIVORSHIP, ACCOMPANIED BY EASY-TO-READ TRIAL SUMMARIES.
named programs · 4 · from sources

what they call their work

I-SPY 2 Trial
Adaptive phase 2 clinical trial platform for high-risk, early-stage breast cancer that uses advanced imaging and biomarkers to match investigational treatments to patients based on tumor biology
I-SPY Advocate Program
A program involving breast cancer survivors and patients who advocate for their own health and healthcare, participate in working groups, and review patient-centric communications for the I-SPY trials.
Patient Advocate Program
Engages breast cancer survivors and patient advocates in trial design, communication, and governance to ensure patient-centered research
Patient Engagement Lead
Manages follow-up data projects for the I-SPY 2 Trial, develops strategies to strengthen patient engagement, and oversees the I-SPY Advocate group.
activities · 5 clusters

what they do

  • Adaptive Platform Trials for Breast Cancer Therapies 11 activities
    • Conducts I-SPY Phase 1b for metastatic breast cancer
      Operates I-SPY Phase 1b, an open-label platform study evaluating single agents or combinations in the treatment of metastatic breast cancer.
    • Conducts I-SPY trials for metastatic and ARDS/COVID applications
      Expands the I-SPY platform to conduct Phase 1b trials for metastatic breast cancer and the I-SPY 2 COVID/ARDS trial to identify therapies that reduce mortality and mechanical ventilation duration in ARDS patients.
    • Conducts RECAST DCIS trial for non-invasive breast cancer
      Runs the Phase 2 RECAST DCIS platform trial across 40 U.S. sites to evaluate investigational endocrine therapies and active surveillance as alternatives to surgery for Ductal Carcinoma In Situ (DCIS), aiming to prevent progression to invasive breast cancer.
    • Conducts RECAST DCIS trial for noninvasive breast cancer
      Runs the Phase 2 RECAST DCIS platform trial to evaluate alternative treatments for ductal carcinoma in situ (DCIS), including active surveillance and investigational endocrine therapies, with the goal of reducing unnecessary surgery; enrolling over 300 patients across 40 U.S. sites in collaboration with pharmaceutical partners.
    • Conducts adaptive clinical trials for breast cancer treatments
      Leads the I-SPY 2 Trial, an adaptive platform trial for neoadjuvant treatment of locally advanced breast cancer, conducted at approximately 50 clinical sites nationwide to evaluate drug efficacy and safety while reducing trial duration and participant numbers.
    • Conducts research on DCIS treatment alternatives
      Conducts the RECAST DCIS Phase 2 platform trial to evaluate noninvasive treatment approaches and active surveillance for Ductal Carcinoma In Situ (DCIS), aiming to reduce unnecessary surgery; enrolls over 300 patients across 40 U.S. sites in collaboration with pharmaceutical partners.
    • Delivers clinical trial treatment for breast cancer patients
      Provides neoadjuvant drug therapy as part of clinical trial treatment for newly diagnosed patients with locally advanced breast cancer, including participation in investigational drug trials.
    • Delivers neoadjuvant clinical trial treatment for breast cancer
      Provides neoadjuvant drug therapy as part of investigational clinical trials for newly diagnosed patients with locally advanced or aggressive breast cancer, including triple-negative subtypes, resulting in documented pathologic complete responses.
    • Delivers neoadjuvant drug therapy in clinical trials
      Administers investigational neoadjuvant drug therapies to newly diagnosed breast cancer patients as part of clinical trial treatment protocols.
    • Facilitates patient participation in clinical trials with measurable outcomes
      Supports patient enrollment in clinical trials resulting in documented pathologic complete responses, including cases involving triple-negative breast cancer and ER+/HER2- subtypes, with long-term follow-up and engagement strategies.
    • Tests investigational drugs in metastatic and advanced breast cancer
      Conducts Phase 1b and Phase 2 investigational drug trials through the I-SPY platform, including testing over 20 experimental agents in combinations or as single agents for metastatic and locally advanced breast cancer, with more than a dozen showing superior benefit to standard therapy.
  • I-SPY 2 Trial Biomarker and Imaging Monitoring 10 activities
    • Collects biomarker and molecular data in clinical trials
      Collects tumor biopsies and conducts biomarker and molecular testing to assess treatment response in the I-SPY 2 Trial and related studies.
    • Conducts adaptive clinical trials for breast cancer treatments
      Leads the I-SPY 2 Trial, an adaptive platform trial for neoadjuvant treatment of locally advanced breast cancer, conducted across approximately 50 U.S. clinical sites to evaluate drug efficacy and safety while reducing trial duration and participant numbers.
    • Monitors tumor response during treatment using MRI
      Uses serial 3D MRI scans at defined intervals during the I-SPY 2 Trial to monitor tumor response in patients receiving neoadjuvant drug therapy for breast cancer.
    • Monitors tumor response using MRI during clinical trials
      Uses 3D and serial MRI scans at defined intervals to monitor tumor response during neoadjuvant treatment in the I-SPY 2 Trial for locally advanced breast cancer.
    • Monitors tumor response via MRI in clinical trials
      Uses 3D and serial MRI scans at defined intervals to monitor tumor response during neoadjuvant treatment in the I-SPY 2 Trial.
    • Tests investigational drugs in breast cancer through the I-SPY platform
      Has tested over 20 investigational drugs through the I-SPY trial platform, with more than a dozen showing greater benefit than standard therapy, including combination therapies like (Z)-Endoxifen with Abemaciclib for ER+/HER2- breast cancer.
    • Uses biomarker and molecular testing to assess treatment response
      Collects tumor biopsies and performs biomarker and molecular analysis in the I-SPY 2 Trial to evaluate treatment response and guide therapy development for breast cancer patients.
    • Uses biomarker and molecular testing to assess treatment response
      Collects tumor biopsies and uses liquid biopsies to analyze biomarkers and predict treatment response and side effects in early-stage breast cancer patients enrolled in the I-SPY 2 Trial.
    • Uses liquid biopsies to predict treatment outcomes in breast cancer
      Conducts research using non-invasive liquid biopsies to predict treatment response and side effects in early-stage breast cancer patients enrolled in the I-SPY 2 trial.
    • Uses liquid biopsies to predict treatment response in breast cancer
      Conducts research using non-invasive liquid biopsies to predict treatment response and side effects in early-stage breast cancer patients enrolled in the I-SPY 2 trial.
  • Clinical Trial Equity Initiatives 3 activities
    • Improves access to clinical trials for under-represented populations
      Implements the ACCESS initiative to rebuild trust and increase participation of under-represented communities in clinical trials through targeted outreach and engagement strategies.
    • Improves access to clinical trials for underrepresented populations
      Works to rebuild trust and improve access to clinical trials for underrepresented populations through the ACCESS initiative.
    • Improves diversity and access in clinical trials
      Runs the ACCESS initiative to rebuild trust and improve access to clinical trials for under-represented populations, enhancing equity in research participation.
  • Clinical Trials and Health Studies 2 activities
    • Manages patient engagement and follow-up in clinical trials
      Conducts follow-up data projects and patient engagement strategies for the I-SPY 2 Trial to support long-term research outcomes and participant retention.
    • Manages patient follow-up and engagement in clinical trials
      Conducts follow-up data projects and patient engagement activities for the I-SPY 2 Trial to support long-term participation and data collection.
  • Uncategorized 7 activities
    • Conducts I-SPY ARDS/COVID research for respiratory disease
      Runs the I-SPY 2 COVID/ARDS program to identify therapies that reduce mortality and mechanical ventilation duration in Acute Respiratory Distress Syndrome (ARDS) patients, expanding the I-SPY platform beyond oncology.
    • Conducts I-SPY research on ARDS and COVID-19 therapies
      Runs the I-SPY 2 COVID/ARDS expansion trial to identify treatments that reduce mortality and mechanical ventilation duration in patients with Acute Respiratory Distress Syndrome, including those affected by COVID-19.
    • Provides 1:1 clinical trial navigation support
      Offers personalized clinical trial navigation through BreastCancerTrials.org to help patients find, understand, and enroll in appropriate breast cancer clinical trials.
    • Provides clinical trial matching and navigation for breast cancer patients
      Operates BreastCancerTrials.org, a non-profit service offering free, unbiased, and customized clinical trial matching and 1:1 navigation support for breast cancer patients across the U.S., including metastatic cases, via an online platform that delivers ongoing trial alerts.
    • Provides clinical trial matching for breast cancer patients
      Operates the only non-profit breast cancer trial matching service in the U.S., offering free, unbiased, and customized matching for patients seeking clinical trials, including metastatic breast cancer trials, via an online platform with ongoing alert capabilities.
    • Provides clinical trial matching for breast cancer patients
      Operates the only non-profit breast cancer trial matching service in the U.S., offering free, unbiased, and customized clinical trial matching for patients with breast cancer, including metastatic cases, through an online platform and 1:1 navigation support via BreastCancerTrials.org.
    • Tests investigational drugs in breast cancer through I-SPY platform
      Has tested over 20 investigational drugs within the I-SPY trial framework, with more than a dozen showing greater benefit than standard therapy, including combination therapies like (Z)-Endoxifen with Abemaciclib for ER+/HER2- breast cancer.
financials · form 990 · fy2022

the money

revenue
Total revenue$47.25M
Contributions & grants$18.94M40%
Program service revenue$27.87M59%
Investment income$451K1%
Other revenue$0
expenses
Total expenses$47.24M
Program expenses94%
Admin / overhead6%
Fundraising1%
Salaries & benefits$16.16M
Grants paid out$0
Largest expense lineCompensation
balance sheet
Total assets$60.91M
Cash$9.21M
Investments$37.86M
Liabilities$30.87M
Net assets$30.04M
Liquid reserves12.0 mo
3 years on record · 2020–2022 · YoY revenue -15.8%
leadership · form 990 part vii · fy2022

who runs it

paid leadership · 9
NameTitleHours/wkCompensation
JAMES PALAZZOLO CEO 60 $549K
KATHRYN WATSON-FEINER VICE PRESIDENT OF FINANCE AND ADMINISTRATION 60 $318K
KARYN DIGIORGIO CHIEF COLLABORATION OFFICER 60 $312K
PAUL HENDERSON SR. DIRECTOR OF COLLABORATIONS 60 $276K
TRACEY HEATHER DIRECTOR OF DEVELOPMENT 60 $275K
MARIA PITSIOUNI DIRECTOR, CLINICAL OPERATIONS ONCOLOGY 60 $251K
SARA HORTON EXECUTIVE DIRECTOR, ACCESS & DIVERSITY 60 $240K
ADAM ASARE CHIEF DATA OFFICER 60 $224K
DAVE MANDELKERN CHAIRMAN 12 $120K
board members · 12
  • ANNA BARKER — DIRECTOR
  • GREGORY C SIMON — DIRECTOR
  • JEFFREY PFEFFER — DIRECTOR, COFOUNDER
  • LAMBERT VAN DER WALDE — DIRECTOR
  • LAURA ESSERMAN — DIRECTOR, COFOUNDER
  • LUCAS DE BREED — DIRECTOR
  • MARK SIMON — DIRECTOR
  • MICHELE MARKUS — DIRECTOR
  • N MARCUS THYGESON — DIRECTOR
  • ROBERT PATTERSON — DIRECTOR
  • ROBYN LAWRIE RUTLEDGE — DIRECTOR
  • SUSAN FOLEY — TREASURER
relationships · 76

who they work with

  • ASCO Partner — Collaborates with patient advocates affiliated with ASCO on grant review and research input.
  • ASCO Partner — Organization with which Quantum Leap-affiliated advocates serve as grant reviewers and members.
  • Agendia, Inc. Partner — Provides MammaPrint Test resources used in the I-SPY 2 Trial
  • Atossa Therapeutics Partner — Collaborates on the RECAST DCIS Phase 2 platform trial.
  • Atossa Therapeutics Partner — Collaborates with Atossa Therapeutics on the I-SPY 2 trial combining (Z)-Endoxifen with Abemaciclib for ER+/HER2- breast cancer.
  • Atossa Therapeutics Partner — Collaborates with Quantum Leap Healthcare Collaborative on the I-SPY 2 Trial and the RECAST DCIS platform trial.
  • Breast Cancer Care & Research Fund Partner — Organization linked to Quantum Leap through shared advocacy and board membership.
  • Breast Cancer Care & Research Fund Partner — Works with board members and advocates linked to this organization to advance breast cancer research and care.
  • BreastCancerTrials.org Partner — Provides clinical trial matching tools and nurse navigator services in partnership with Quantum Leap Healthcare Collaborative.
  • City of Hope Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Cleveland Clinic Taussig Cancer Center Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Columbia Herbert Irving Comprehensive Cancer Center Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Columbia University Partner — Hosts I-SPY 2 Trial Investigator and Patient Reported Outcomes Committee Co-Chair Dawn Hershman at the Herbert Irving Comprehensive Cancer Center
  • Emory University Winship Cancer Institute Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Evinova Partner — Partners with Evinova to incorporate real-time remote patient monitoring into the breast cancer platform trial.
  • Genentech Partner — Collaborates with researchers who have prior experience in clinical pharmacology at Genentech, indicating industry research ties.
  • Georgetown University Lombardi Cancer Center Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Havah Therapeutics Partner — Collaborates on the RECAST DCIS Phase 2 platform trial.
  • Havah Therapeutics Partner — Collaborates with Quantum Leap Healthcare Collaborative on the RECAST DCIS platform trial.
  • Hoag Family Cancer Institute Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Lobular Breast Cancer Alliance (LBCA) Partner — Collaborates on grant review and research initiatives related to lobular breast cancer.
  • Lobular Breast Cancer Alliance (LBCA) Partner — Organization with which Quantum Leap-affiliated advocates collaborate on research and grant review.
  • Loyola University Cardinal Bernardin Cancer Center Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Mayo Clinic Partner — Hosts I-SPY 2 Surgery Committee Chair Judy Boughey in Rochester, Minnesota
  • Mayo Clinic Breast Cancer Center–Rochester Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Menarini Group Partner — Collaborates with Quantum Leap Healthcare Collaborative on the RECAST DCIS platform trial.
  • Moffitt Cancer Center Partner — Participating site in the I-SPY 2 Trial conducting clinical research under the Quantum Leap Healthcare Collaborative protocol.
  • Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard Partner — Engages patient advocates as reviewers in clinical trial design and oversight.
  • Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard Partner — Organization for which Quantum Leap-affiliated advocates serve as reviewer members.
  • National Breast Cancer Coalition Coalition — Organization through which patient advocates affiliated with Quantum Leap participate in training and policy work.
+ 46 more