PRE-I-SPY Phase 1 Trial

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PRE-I-SPY Phase 1 Trial

Helpful information to learn more about the PRE-I-SPY trial.

Who is eligible for the PRE-I-SPY trial?

Women and men who are:

At least 18 years old
Have advanced (some stage III) or metastatic (stage IV) cancer, including breast cancer, that is growing or spreading in spite of prior treatments

If you meet these requirements, you are eligible to be screened for participation in the PRE-I-SPY trial. This means that your study doctor will check to make sure it is safe for you to take part in the study. This includes checking your heart, liver, and kidney function. You will have a biopsy (tissue sample of your tumor) and testing that identifies the genetic code in your cancer (not in your body’s genetic code). This information helps the doctors understand the behavior of the cancer and help select treatment for your cancer.

Why should I consider joining?

By participating in a clinical trial like PRE-I-SPY, you will receive additional care and more frequent visits than what you would receive outside of a trial. Participating in a trial like PRE-I-SPY may offer access to new treatments that may one day become the best-known treatment available. By participating in a trial, you’re also contributing to research that could help others with advanced cancers in the future.

What is the purpose of the PRE-I-SPY trial?

We are doing this study because we want to determine the safety of giving combinations of study drugs at different doses as treatment to people with certain advanced cancers. We also want to see if giving these drugs together shrinks your cancer or stops it from growing.

The PRE-I-SPY trial may also help the study doctors find out if this treatment approach is better, the same, or worse than the usual treatment approach for your type of cancer.

The trial will also gather early information to help decide if these treatments should be studied further in larger trials, like I-SPY 2.2 or other phase II/III studies.

What will happen if I decide to take part in this study?

Before you begin treatment in the PRE-I-SPY trial, your tumor will be tested for biomarkers, which tell us more information about the type of tumor you have. Based on the results, you will receive a treatment that targets your tumor type. This approach is called precision medicine.

If you decide to take part in this study, you will be given study drugs in repeating treatment cycles as long as you do not have severe (unbearable) side effects and there is no growth of your cancer. Each treatment cycle lasts 28 days (~1 month).

After you finish your study participation, your study doctor will continue to follow your condition every 12 weeks (~3 months) for 1 year and then every 24 weeks (~6 months) in order to check for side effects. Follow ups may be done by phone or by your electronic health records (your chart).

What should I expect if I join the trial?

If you decide to join the trial, you will speak with a clinical trial team member to determine if you are a match for the study. If you are a potential candidate, you will be asked to sign a form to give your consent for the study staff to perform tests and collect your health information.

For more information or if you are interested in learning more, please contact the site nearest you. Click here for site list and contact information.

What should I do next?

Have questions about clinical trials? We can help guide you to answers.

Making Your Decision

Why Trials Are Important

Carefully conducted clinical trials give researchers and breast cancer patients the opportunity to work to together to advance all aspects of breast cancer care.

Understanding more about clinical trials:

https://www.breastcancertrials.org/BCTIncludes/WhyParticipate/TreatmentTrials/index.html

Dictionary of Cancer Terms

Find easy-to-understand definitions of terms related to cancer and medicine.

Crystal Hendricks-Kretzer

Crystal Hendricks-Kretzer was diagnosed with Stage IIb Triple Positive (ER+, PR+, HER2+) breast cancer in June of 2023. The moment she heard from her breast surgeon and oncologist at the University of Chicago that she could join a clinical trial, she signed up. Crystal participated in I-SPY 2.2 with great success (achieving a pathologic complete response) and wrapped up active treatment in September 2024. It was important for her to use this diagnosis for the greater good, as she knew the only reason she had access to the best treatments for her cancer was because of the women who participated in trials decades before.

Crystal is a member of the National Breast Cancer Coalition, participating in both their Leadership Summit and Project LEAD; a member of ASCO; a merit reviewer with PCORI; and an advocate reviewer with the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard. With I-SPY, Crystal is active in a number of working groups and reviews patient-centric communications.

When not thinking about cancer, Crystal is a freelance grant writer and communications consultant, working with clients from NYC to LA and beyond. She is an avid reader, crocheter, Peloton rider, and wannabe lifter of heavy things. She lives in Chicago with her husband and a revolving door of foster dogs.

Deborah Romer

Deborah’s breast cancer diagnosis in late 2022 catalyzed her interest in breast cancer research and patient advocacy following a complicated diagnosis. She is pleased to be participating as a patient advocate at UCSF, as well as with state, national and international groups, and has channeled her research and health care background in her advocacy work.

Deborah is a member of the National Breast Cancer Coalition and attended their Project Lead Science Training program in the summer of 2024, and will complete their Public Policy Institute in 2025. She serves on the Research Committee of the Lobular Breast Cancer Alliance (LBCA) and has been a grant reviewer for ASCO and LBCA. She begun working with Dr. Rita Mukhtar at UCSF on lobular breast cancer research and served on a panel for the Annual UCSF Breast Oncology Program Retreat. Deborah joined as a new member of the UCSF I-SPY Patient Advocate Panel in 2025 and serves as a Board member of Breast Cancer Care & Research Fund which links education, research and care to end breast cancer.

Throughout Deborah’s 30 plus year career in health care administration, she has worked to make health care more inclusive, accessible, equitable and personal. She started her health care career at the Stanford School of Medicine and then worked with several hospitals and health systems, including Kaiser Permanente where she worked for 22 years, serving as a medical group administrator and hospital CEO in Northern California, then at the National level as Vice President for Patient and Service Quality and as an Executive for National Quality and Board Governance.

Deborah is passionate about the importance of evidence-based research and multi-specialty team collaboration in solving problems and is committed to advancing breast cancer research, to supporting researchers, clinicians and patients, and to ensuring that the patients’ perspective is integrated into research, clinical trials and care. She has a BA with Highest Honors in Sociology and Research Methods from the University of California, Santa Cruz and a MBA from the Anderson School of Management at UCLA. She enjoys opera, jazz and the performing arts, as well as hiking, dancing and traveling, and is excited to be moving back to San Francisco in spring, 2025.

Tracey Heather

Advocate Liaison

As Patient Engagement Lead at Quantum Leap, I manage follow-up data projects for the I-SPY 2 Trial, develop strategies to strengthen patient engagement, and oversee the I-SPY Advocate group. After six successful years raising funds to support Quantum’s mission, I embraced this new role last summer, drawn by the opportunity to make a direct impact on the patients we serve. Each day brings new challenges and insights, and I especially enjoy supporting and collaborating with our inspiring I-SPY Advocates.

Outside of work, I am pursuing a Master of Public Administration with a focus on nonprofit management at SF State. I’m passionate about trail running, skiing, live music, camping, traveling, and collegiate gymnastics—my daughter competes at Oregon State. For the past 5 years, I have volunteered with SF CASA as a mentor to an incredible 18-year-old foster youth whose resilience continually reminds me of life’s true priorities.

Carolyn Clark Beedle

Carolyn Clark Beedle, a 2023 breast cancer survivor, joined the advocate program after successful completion of treatment with the UCSF Breast Oncology Program. Her experience working with a patient advocate during her TNBC treatment led to an understanding that empowering women to advocate for their own health and healthcare will contribute to improved health outcomes and broader access to care. Carolyn began advocating for cancer patients and their families during her treatment, now is a member of the Breast Science Advocacy Core (BSAC) with the UCSF Breast Oncology Program, and currently shares information and research with CFNP associates at La Clinica in the Bay Area to inform and empower their patient population.

Carolyn is continuing her on the ground training as an advocate reviewer with both Quantum Health and BSAC and is enrolled in the Patient Advocacy Training in Health Science course with Stanford Medicine. Her 30+ career in corporate marketing/communications, program development and non-profit leadership augmented by her breast cancer treatment experience serves Carolyn well in representing and communicating the patient voice and perspective.

She received her BA (History/English Lit) and MA (Public History/Research and Record Management) from the University of San Diego, is a proud fifth generation San Franciscan, and active board member with numerous non-profits that support social work and the arts.

Silver Alkhafaji

Silver Alkhafaji is a PhD candidate in the Pharmaceutical Sciences and Pharmacogenomics (PSPG) program at UCSF. She received her Bachelor of Science in Chemical Biology from UC Berkeley. Prior to UCSF, she worked in the Clinical Pharmacology Department at Genentech. Silver’s current research focuses on non-invasive liquid biopsies to predict response and side effects of immunotherapies and endocrine therapies in early-stage breast cancer participants in I-SPY 2.

Silver is interested in clinical outcomes research to advance precision medicine and improve cancer patients’ quality of life. She is passionate about health equity, inclusive research, patient advocacy, and women’s health.
Silver volunteers at the Patient and Family Cancer Support Center at UCSF where she assists in patient navigation and connecting patients and their families with resources that improve their healthcare experience while receiving cancer treatments and/or during survivorship.   Through her DEI work in her PhD program, Silver raises awareness around issues related to social justice and community building through organizing community-centered events. Additionally, she is a member of the Life Sciences Career Advisory Council at Thrive Scholars, where she enjoys supporting college students of color from economically disadvantaged communities in providing the opportunities they need to thrive at top colleges and in high-trajectory careers.   Silver is a member of the American Association of University Women (AAUW) Alameda Branch where she focuses her efforts on increasing membership of community college women coming from exceptional backgrounds: student parents, low-income, and first-generation college students.

In her free time, she writes poetry and prose on emotional healing, radical acceptance, and patience. Writing has helped her process difficult situations and connect with people on a deeper level.

Jane Mortimer

Jane is a breast cancer survivor and advocate dedicated to positively impacting the lives of women affected by the disease. Diagnosed with triple negative breast cancer in 2012, she participated in the I-SPY 2 trial at UCSF and has been cancer free for more than ten years.

Her advocacy journey began in 2003 at UCSF as a volunteer with the Patient and Family Cancer Support Center and Decision Support Services and she previously managed the Peer Support program at UCSF. Drawing on her experience in marketing and media strategy, she uses her skills to make a meaningful impact by supporting advocacy and research that improves outcomes for women living with breast cancer.

Jan Tomlinson

In March of 2023 , Jan was diagnosed with a large aggressive triple negative breast cancer and informed that her cancer was the” bad girl” of cancer and offered standard chemotherapy for 24 weeks. Devasted by the diagnosis Jan felt like she had a dire prognosis. After seeking several opinions, she opted to join a Clinical Trial program for her treatment. The trial consisted of significantly less chemotherapy, and monitored closely over a 12-week period, The data predicted a complete pathological response , and she then went immediately to surgery. Pathology reports supported that she had a successful outcome reaching PCR meaning the tumor was gone, and no residual cancer was found in the surrounding tissue or lymph nodes. Jan was thrilled when her surgeon advised her of the results. The experience made Jan want to give back and share information that she received when she was at a critical juncture in her diagnosis. She is so passionate about making sure that everyone knows that the standard of care is one treatment option.

As she says, “ clinical trials have to be on the table” Because she achieved PCR, she expects a great outcome. She wants to share her story and encourage other women to strongly consider and participate in clinical trials. Jan is a UCSF Patient Advocate, involved in several programs they lead. Jan also is a BLACC Cab Member. Jan recently was in Washington DC to participate on a panel on Clinical Trials for ISPY at the National Press Club. UCSF will be hosting the RISE Up For Breast Cancer event where Jan will share her experience with clinical trials.

Deborah Collyar

Deb is a connector who founded Patient Advocates in Research (PAIR) “where research meets reality,” bringing ideas and people together for medical advances that offer real results for diverse patients and families.

Her vast experience between the worlds of tech, communication, strategy, management, policy, and equity bridges gaps between patients, scientists, medical providers, payers, governments, and non-profits.

Deb infuses patient engagement into projects, gathers relevant patient input, and encompasses many diseases, programs and policies at grassroots, national and international levels through companies, academia, and governments.

Key patient insights are delivered throughout discovery, development, clinical trials, results reporting, data-sharing, standards, genomics, and into practice.

Her experience spans translational and clinical research, epidemiology, health outcomes, and health delivery research with academia, federal agencies, companies, and patient communities.