Breast CancerPhase 2SPOCKNCT04965688
Biology Guided Therapy for Breast Cancer for ER Positive
A Phase 2 study testing Biopsy-Guided Therapy Selection in people with Breast Cancer and Estrogen Receptor-positive Breast Cancer, run by Inova Health Care Services at 1 site in United States.
Trial summary
There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- Biopsy-Guided Therapy Selection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2021to 13 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of breast cancer
- Metastatic or incurable
- Prior treatment with an anastrozole or letrozole and a CDK4/6 inhibitor
- Progression while on or within 6 months of stopping the CDK4/6 inhibitor
- At least one lesion amenable to percutaneous biopsy that is not a purely sclerotic bone lesion
- ECOG 0-2
- Age 18 or greater
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Prior treatment within 2 years with fulvestrant, alpelisib, everolimus, or capecitabine
- Comorbid disease other than breast cancer with a life expectancy of less than 2 years
- Cancer other than breast cancer that is expected to need treatment within 2 years
- Platelets < 100,000/microliter
- INR > 1.5
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
About this study
Official title: Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition
There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.
Read the detailed description
This is an open-label phase II study of systems biology guided therapy for breast cancer patients positive for Oestrogen receptor after Aromatase inhibitor and CDK inhibition.
Based on the SOLAR-1 trial, 25% of tumors would have PIK3CA mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median PFS in that group of 11 months and 75% of people would be treated with fulvestrant with a median PFS in that group of 6 months.(3) The weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median PFS of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.
- Being tested
- Biopsy-Guided Therapy Selection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy-Guided Therapy SelectionDrug
All enrolled participants will undergo a tumor biopsy, which will be analyzed for genomic and transcriptomic alterations using FoundationOne (DNA) and Fulgent (RNA). Based on the genomic findings, participants will receive one of the following therapy standard-of-care treatment options:
PI3K inhibitor + anti-estrogen therapy ( alpelisib + fulvestrant)
MTOR inhibitor + anti-estrogen therapy (everolimus + exemestane)
Anti-estrogen therapy alone (fulvestrant monotherapy)
Cytotoxic chemotherapy (capecitabine)
| Study group | Role | What they receive |
|---|---|---|
| Personalized Cancer Treatment Based on Biopsy Results | Other | Not described Receives: Drug: Biopsy-Guided Therapy Selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Baseline to 36 Months
Secondary outcomes (3)
Turn Around Time for Systems Biology Analysis
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Baseline to 36 Months
Response Rate to Systems Biology Guided Therapy
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Baseline to 36 Months
Progression Free Survival Base on Concordance With Recommended Treatment
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Baseline to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start8 Aug 2021
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Why it stopped: Lack of enrollment to meet the primary and secondary study goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, interventional
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope Medical Center
- Responsible party
- Sponsor
- Investigators
- Adam Cohen, MD, Principal investigator, Inova Schar Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965688
- Sponsor's protocol ID
- U21-02-4401
- Acronym
- SPOCK
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2021
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology Guided Therapy for Breast Cancer Positive for Oestrogen Receptor After Aromatase Inhibitor and CDK Inhibition
- ClinicalTrials.gov ID
- NCT04965688
- Acronym / sponsor ID
- SPOCK / U21-02-4401
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment to meet the primary and secondary study goals
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- City of Hope Medical Center
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.
Detailed description
This is an open-label phase II study of systems biology guided therapy for breast cancer patients positive for Oestrogen receptor after Aromatase inhibitor and CDK inhibition.
Based on the SOLAR-1 trial, 25% of tumors would have PIK3CA mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median PFS in that group of 11 months and 75% of people would be treated with fulvestrant with a median PFS in that group of 6 months.(3) The weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median PFS of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, interventional
| Arm | Type | Receives |
|---|---|---|
| Personalized Cancer Treatment Based on Biopsy Results | Other | Drug: Biopsy-Guided Therapy Selection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic diagnosis of breast cancer
- Metastatic or incurable
- Prior treatment with an anastrozole or letrozole and a CDK4/6 inhibitor
- Progression while on or within 6 months of stopping the CDK4/6 inhibitor
- At least one lesion amenable to percutaneous biopsy that is not a purely sclerotic bone lesion
Key exclusion criteria (5 listed)
- Prior treatment within 2 years with fulvestrant, alpelisib, everolimus, or capecitabine
- Comorbid disease other than breast cancer with a life expectancy of less than 2 years
- Cancer other than breast cancer that is expected to need treatment within 2 years
- Platelets < 100,000/microliter
- INR > 1.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy-Guided Therapy SelectionAll enrolled participants will undergo a tumor biopsy, which will be analyzed for genomic and transcriptomic alterations using FoundationOne (DNA) and Fulgent (RNA). Based on the genomic findings, participants will receive one of the following therapy standard-of-care treatment options: PI3K inhibitor + anti-estrogen therapy ( alpelisib + fulvestrant) MTOR inhibitor + anti-estrogen therapy (everolimus + exemestane) Anti-estrogen therapy alone (fulvestrant monotherapy) Cytotoxic chemotherapy (capecitabine) | Drug | Personalized Cancer Treatment Based on Biopsy Results |
Primary outcome
Progression Free Survival
Time frame: Baseline to 36 Months
No data displayed because Outcome Measure has zero total participants analyzed.
3 secondary outcomes
Turn Around Time for Systems Biology Analysis
Time frame: Baseline to 36 Months
Response Rate to Systems Biology Guided Therapy
Time frame: Baseline to 36 Months
Progression Free Survival Base on Concordance With Recommended Treatment
Time frame: Baseline to 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Cohen, MD principal investigator
Inova Schar Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biopsy-Guided Therapy Selection in people with Breast Cancer and Estrogen Receptor-positive Breast Cancer, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Baseline to 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.