Triple Negative Breast CancerPhase 2NCT05233696
Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC
A Phase 2 study testing Nab-paclitaxel, Paclitaxel and Radiation Therapy in people with Triple Negative Breast Cancer and Locally Advanced Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Unresectable Breast Carcinoma
- What is being tested?
- Nab-paclitaxel, Paclitaxel and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form including non-English speaking and non-reading participants.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male or female aged ≥ 18 years.
- Metastatic or locally advanced unresectable histologically documented TNBC as defined by absence of estrogen receptor (ER) and progesterone receptor (PR) expression and no HER2 amplification or over-expression by local pathology report.
- HER2 negativity is defined as either: in situ hybridization non-amplified (ratio of HER2 to CEP17 < 2 or single probe average HER2 gene copy number < 4 signals/cell OR IHC 0 or 1+).
- ER and PR negativity is defined as < 1% positive by IHC.
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- Treatment with < 1 prior line of systemic therapy in the metastatic setting or adjuvant/neoadjuvant setting if metastatic recurrence within 12 months of treatment.
- Confirmed PD-L1 positive as defined by Combined Positive Score (CPS) > 10% by a CLIA-certified lab
- At least one site of disease amenable to radiation therapy.
- Clinically appropriate for treatment with nab-paclitaxel/paclitaxel plus pembrolizumab in the opinion of the treating investigator.
- If the maximum number of non-biopsy subjects has accrued to the study, willingness to undergo 2 tumor biopsies and disease amenable to safe biopsy in the opinion of the treating investigator. NOTE: Tumor biopsies may be required, depending on the number of subjects who have agreed to undergo correlative studies.
- Life expectancy of > 3 months per treating investigator.
- ECOG performance status ≤ 1.
- Baseline labs must meet the following criteria within 21 days of radiation initiation:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- Platelets ≥ 100,000/mcL.
- Hemoglobin ≥ 9.0 g/dL.
- Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) or ≤ 3 x ULN for subjects with Gilbert's disease.
- AST (SGOT)/ALT (SGPT) ≤ 3 X institutional ULN or ≤ 5 X institutional ULN in liver metastasis are present.
- Serum creatinine < 1.5 X institutional ULN.
- INR and PTT < 1.5 X institutional ULN. This applies only to patients undergoing serial tumor biopsies.
- All prior reversible treatment-related toxicities must have resolved to CTCAE v5.0 criteria of grade 1 or less (except alopecia).
- Women must not be pregnant or breastfeeding.
- Women of childbearing potential must have a negative pregnancy test before enrollment. Women who are not of childbearing potential defined as post- menopausal (amenorrheic for > 12 months) or undergone prior hysterectomy or bilateral salpingo-oophorectomy do not require pregnancy testing.
- Willingness of male and females who are of childbearing potential to use medically acceptable contraception for the duration of the study, including 30 days after last dose of nab-paclitaxel/paclitaxel and 6 months after last pembrolizumab, whichever is longer. Male patients must refrain from donating sperm during these periods.
- Availability of archival tumor tissue (core biopsy or surgical tumor blocks) for analysis. Sites will be asked to submit archival tissue (subjects may start the study if tissue is available at an outside hospital, but not yet requested or received).
Who cannot join
- Any of the following interventions within the specified time frame prior to radiation:
- Radiation therapy within 21 days.
- Cytotoxic chemotherapy within 21 days (capecitabine within 14 days).
- Monoclonal antibodies within 21 days.
- Administration of an investigational agent that is not expected to be cleared prior to initiation of radiation.
- More than one prior line of chemotherapy in the locally advanced unresectable or metastatic setting.
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- Prior treatment with a taxane in the metastatic setting. Prior taxane in the curative setting is allowed if treatment was completed ≥ 6 months prior to metastatic recurrence.
- Prior receipt of immune checkpoint inhibitor (PD-L1, PD-1 or CTLA-4 inhibitors) less than 12 mos from metastatic recurrence.
- Patients with active collagen vascular disease (CVD), specifically systemic lupus erythematosus or scleroderma. Patients with a history of CVD without evidence of active disease are eligible for enrollment at the discretion of the study PI.
- History of immunodeficiency, hypersensitivity to pembrolizumab or other medical contraindication to receipt of immunotherapy.
- Has active, or history of, pneumonitis requiring treatment with corticosteroids.
- Has a known history of active tuberculosis.
- Has a known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome - related illness (testing not required at screening).
- Has known active hepatitis B (hepatitis B surface antigen reactive) or hepatitis C (qualitative HCV RNA is detected) (testing not required at screening).
- Has received a live vaccine within 30 days prior to enrollment.
- Has an active infection requiring treatment with oral or IV medication. Patients on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other criteria are met.
- Autoimmune disease that has required systemic treatment in the past 2 years (ie. with the use of disease modifying agents, systemic corticosteroids, or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Symptomatic or uncontrolled central nervous system (CNS) metastases. Patients with treated brain metastasis with stable CNS imaging > 28 days after radiation and no requirement for corticosteroids are eligible.
- Receipt of corticosteroid therapy at greater than physiologic dosing in the investigator's opinion within 14 days of the start of radiation therapy.
- For patients undergoing serial tumor biopsies, known bleeding diathesis or history of abnormal bleeding or require anti-coagulation therapy that cannot be interrupted for biopsy.
- Patients with a separate active cancer diagnosis for which the patient has not been without evidence of disease for at least 2 years.
- Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study.
- Any severe concurrent disease or condition (including uncontrolled diabetes mellitus, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, or cardiac arrythmia) which, in judgment of the Investigator, would make the patient inappropriate for study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Phase II Study of Radiotherapy in Combination With Chemotherapy and Immunotherapy in Patients With PD-L1-Positive Metastatic Triple-Negative Breast Cancer
Patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.
Read the detailed description
Patients with locally advanced unresectable or metastatic PD-L1 positive TNBC will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.
This is a two-stage, single-arm phase II study. Utilizing time-to-event outcomes, the investigators assumed an uninteresting 1-year PFS rate of 39% and a positive 1-year PFS rate of 60%. The first stage will enroll 17 subjects, with an additional 12 subjects to be enrolled in stage 2 if the trial is not stopped due to futility, for a total of 29 subjects. Enrollment will not be paused after the first stage of enrollment. At the time of the interim analysis the investigators would expect approximately 12 patients to have completed 1-year follow-up.
- Conditions
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer, PD-L1 Gene Mutation
- Being tested
- Nab-paclitaxel, Paclitaxel, Radiation Therapy, Pembrolizumab
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Abraxane
All patients are encouraged to receive nab-paclitaxel 100 mg/m2 IV D1 and D8 every 21 days (in combination with pembrolizumab) for at least 4-6 cycles per institutional standards and treating physicians' recommendations.
PaclitaxelDrug
Also called Abraxane
Paclitaxel can be substituted for nab-paclitaxel at the discretion of the treating physician 80 mg/m2 IV D1 and D8 every 21 days.
Radiation TherapyRadiation
The treating radiation oncologist will select 1-4 sites of metastatic disease to target with radiation. All sites of disease may be targeted with radiation. Sites of metastatic disease planned to be biopsied should not be radiated.
PembrolizumabDrug
Also called Keytruda
Patients will receive pembrolizumab 200 mg D1 every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| RT followed by nab-paclitaxel/paclitaxel plus pembrolizumab | Experimental | Nab-paclitaxel/paclitaxel plus pembrolizumab will be started within 7 days of completion of RT. Receives: Drug: Nab-paclitaxel; Drug: Paclitaxel; Radiation: Radiation Therapy; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year progression free survival rate
To determine the efficacy of radiotherapy in combination with chemotherapy plus immunotherapy as defined by 1-year PFS rate in patients with PD-L1-positive metastatic TNBC.
Measured: 36 months
Secondary outcomes (9)
Rate of in-field tumor control
In-field tumor control will be defined as stable disease (SD), partial remission (PR), or complete remission (CR), of the target lesion, by RECIST 1.1 criteria.
Measured: 36 months
Determine overall response rate (ORR)
Determined by RECIST 1.1
Measured: 36 months
Determine clinical benefit rate (CBR)
Defined as SD, PR + CR, of the target lesion, by RECIST 1.1 criteria.
Measured: 36 months
Duration of response
Duration of response by RECIST 1.1
Measured: 36 months
Progression free survival
PFS will be measured from the date of initiation of nab-paclitaxel/paclitaxel plus pembrolizumab to the time of tumor progression or death from any cause
Measured: 36 months
Evaluate the tolerability of radiotherapy added to the combination of chemotherapy and immunotherapy
Adverse events will be assessed according to NCI CTCAE v5.0.
Measured: 36 months
Evaluate change in immune cell populations by IHC.
Serial tumor biopsies will be obtained in a subset of patients and changes in immune cell populations and activation profiles will be evaluated by IHC.
Measured: 36 months
Evaluate change in immune cell populations in blood samples using flow cytometry and gene expression profiling.
Peripheral blood samples will be obtained pre-treatment and at various timepoints after treatment and evaluated by flow cytometry for B cell, NK cell, and CD8, CD4, and regulatory T cell populations including markers of activation and exhaustion (TIM-3, , LAG-3, and PD-L1) and gene expression. Fold change compared to baseline will be determined.
Measured: 36 months
Evaluate changes in markers of immune cell activation using IHC.
Serial tumor biopsies will be obtained in a subset of patients and changes in immune cell populations and activation profiles will be evaluated by IHC.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start4 Jan 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado
- Responsible party
- Sponsor
- Investigators
- Jennifer Diamond, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233696
- Sponsor's protocol ID
- 21-3117.cc
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Radiotherapy in Combination With Chemotherapy and Immunotherapy in Patients With PD-L1-Positive Metastatic Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05233696
- Acronym / sponsor ID
- 21-3117.cc
- Conditions
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer, PD-L1 Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low Accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cancer League of Colorado
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.
Detailed description
Patients with locally advanced unresectable or metastatic PD-L1 positive TNBC will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.
This is a two-stage, single-arm phase II study. Utilizing time-to-event outcomes, the investigators assumed an uninteresting 1-year PFS rate of 39% and a positive 1-year PFS rate of 60%. The first stage will enroll 17 subjects, with an additional 12 subjects to be enrolled in stage 2 if the trial is not stopped due to futility, for a total of 29 subjects. Enrollment will not be paused after the first stage of enrollment. At the time of the interim analysis the investigators would expect approximately 12 patients to have completed 1-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT followed by nab-paclitaxel/paclitaxel plus pembrolizumab | Experimental | Drug: Nab-paclitaxel, Drug: Paclitaxel, Radiation: Radiation Therapy, Drug: PembrolizumabNab-paclitaxel/paclitaxel plus pembrolizumab will be started within 7 days of completion of RT. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Provision to sign and date the consent form including non-English speaking and non-reading participants.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male or female aged ≥ 18 years.
- Metastatic or locally advanced unresectable histologically documented TNBC as defined by absence of estrogen receptor (ER) and progesterone receptor (PR) expression and no HER2 amplification or over-expression by local pathology report.
- Treatment with < 1 prior line of systemic therapy in the metastatic setting or adjuvant/neoadjuvant setting if metastatic recurrence within 12 months of treatment.
Key exclusion criteria (23 listed)
- Any of the following interventions within the specified time frame prior to radiation:
- More than one prior line of chemotherapy in the locally advanced unresectable or metastatic setting.
- Prior treatment with a taxane in the metastatic setting. Prior taxane in the curative setting is allowed if treatment was completed ≥ 6 months prior to metastatic recurrence.
- Prior receipt of immune checkpoint inhibitor (PD-L1, PD-1 or CTLA-4 inhibitors) less than 12 mos from metastatic recurrence.
- Patients with active collagen vascular disease (CVD), specifically systemic lupus erythematosus or scleroderma. Patients with a history of CVD without evidence of active disease are eligible for enrollment at the discretion of the study PI.
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 |
|---|---|---|
| Nab-paclitaxelAlso: AbraxaneAll patients are encouraged to receive nab-paclitaxel 100 mg/m2 IV D1 and D8 every 21 days (in combination with pembrolizumab) for at least 4-6 cycles per institutional standards and treating physicians' recommendations. | Drug | RT followed by nab-paclitaxel/paclitaxel plus pembrolizumab |
| PaclitaxelAlso: AbraxanePaclitaxel can be substituted for nab-paclitaxel at the discretion of the treating physician 80 mg/m2 IV D1 and D8 every 21 days. | Drug | RT followed by nab-paclitaxel/paclitaxel plus pembrolizumab |
| Radiation TherapyThe treating radiation oncologist will select 1-4 sites of metastatic disease to target with radiation. All sites of disease may be targeted with radiation. Sites of metastatic disease planned to be biopsied should not be radiated. | Radiation | RT followed by nab-paclitaxel/paclitaxel plus pembrolizumab |
| PembrolizumabAlso: KeytrudaPatients will receive pembrolizumab 200 mg D1 every 21 days. | Drug | RT followed by nab-paclitaxel/paclitaxel plus pembrolizumab |
Primary outcome
1 year progression free survival rate
Time frame: 36 months
To determine the efficacy of radiotherapy in combination with chemotherapy plus immunotherapy as defined by 1-year PFS rate in patients with PD-L1-positive metastatic TNBC.
9 secondary outcomes
Rate of in-field tumor control
Time frame: 36 months
Determine overall response rate (ORR)
Time frame: 36 months
Determine clinical benefit rate (CBR)
Time frame: 36 months
Duration of response
Time frame: 36 months
Progression free survival
Time frame: 36 months
Evaluate the tolerability of radiotherapy added to the combination of chemotherapy and immunotherapy
Time frame: 36 months
Evaluate change in immune cell populations by IHC.
Time frame: 36 months
Evaluate change in immune cell populations in blood samples using flow cytometry and gene expression profiling.
Time frame: 36 months
Evaluate changes in markers of immune cell activation using IHC.
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.
Jennifer Diamond, MD principal investigator
University of Colorado, Denver
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 Nab-paclitaxel, Paclitaxel and Radiation Therapy in people with Triple Negative Breast Cancer and Locally Advanced Breast Cancer, run by University of Colorado, Denver 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 26 inclusion and 23 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: withdrawn, as of the sponsor's last update on 6 Dec 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
1 year progression free survival rate (time frame: 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 6 Dec 2022.