Breast CancerPhase 2CIMERNCT04220476
CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab and Palbociclib 125mg in people with Breast Cancer, run by Weill Medical College of Cornell University.
Trial summary
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab and Palbociclib 125mg
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2020to 31 Dec 2028
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 18 years of age pre and post-menopausal
- Oligometastatic disease (≤ 5 sites of disease)
- Premenopausal status is defined as either:
- Patient had last menstrual period within the last 12 months, OR
- If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR
- In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.
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- Patients who have undergone bilateral oophorectomy are eligible.
- Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Biopsy proven diagnosis of HR+HER2- metastatic breast cancer. ER expression is >10%
- Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
- Hematological WBC ≥ 2000/uL
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
- AST (SGOT) and ALT (SGPT) ≤2.5 × ULN
- Coagulation International normalized ratio (INR) OR prothrombin time (PT)
- Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants
Who cannot join
- Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
- Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy
- Male breast cancer patients
- Any lesion >5 cm in greatest diameter.
- Inability to obtain histologic proof of metastatic breast cancer
- Has received previous endocrine or chemotherapy for metastatic breast cancer.
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- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: - - - Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has an active infection requiring systemic therapy. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Patients with uncontrolled brain metastases
About this study
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.
- Conditions
- Breast Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg
- Keywords
- metastatic Breast cancer, HR+HER2-, HR + BC, SBRT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions)Radiation
Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. They will undergo tumor Immunogenic-SBRT(I-SBRT) days 1-12 (+/-2 days, to enable inclusion of holidays). During the week preceding day 1, they will undergo simulation and planning for radiotherapy. Each oligometastatic lesion will be treated with I-SBRT every 48 hours. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions
Letrozole 2.5Mg TabDrug
All patients start standard therapy with oral letrozole (Femara), day 1 of the study.
Palbociclib 125mgDrug
Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 - Letrozole and Palbociclib | Active comparator | Patients randomized to arm 1 will start standard Letrozole followed by Palbociclib at day 21. Receives: Drug: Letrozole 2.5Mg Tab; Drug: Palbociclib 125mg |
| ARM 2 - Letrozole and Palbociclib + I-SBRT | Active comparator | Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions); Drug: Letrozole 2.5Mg Tab; Drug: Palbociclib 125mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects achieving Objective response rate (ORR) will be assessed.
ORR is defined as the percentage of subjects with either a confirmed complete response (CR) or partial response (PR).
Measured: End of study, up to 36 months.
Number of Subjects achieving Progression free survival (PFS)
Progression free survival (PFS) is defined as the time from the start of study treatment until the disease progression or death.
Measured: End of study, up to 36 months.
Number of subjects achieving Overall survival(OS) will be assessed.
OS is defined as the time from the start of treatment until death.
Measured: End of study, up to 36 months.
Secondary outcomes (2)
Serial levels of Circulating tumor DNA (ctDNA)
serial levels ctDNA can be an early indication of progression
Measured: End of study, up to 36 months.
Circulating tumor DNA (ctDNA) levels
Circulating tumor DNA (ctDNA) levels will be measured to determine baseline cancer heterogeneity and its response to treatment
Measured: End of study, up 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 posted7 Jan 2020
- Study start4 Mar 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Why it stopped: Initiating a new study with revised Statistics.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Formenti, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220476
- Sponsor's protocol ID
- 19-09020752
- Acronym
- CIMER
- Status last verified
- Sep 2020
- First submitted
- 3 Jan 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
- ClinicalTrials.gov ID
- NCT04220476
- Acronym / sponsor ID
- CIMER / 19-09020752
- Conditions
- Breast Cancer
- Keywords
- metastatic Breast cancer, HR+HER2-, HR + BC, SBRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Initiating a new study with revised Statistics.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Jan 2020 (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.
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 - Letrozole and Palbociclib | Active comparator | Drug: Letrozole 2.5Mg Tab, Drug: Palbociclib 125mgPatients randomized to arm 1 will start standard Letrozole followed by Palbociclib at day 21. |
| ARM 2 - Letrozole and Palbociclib + I-SBRT | Active comparator | Radiation: Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Drug: Letrozole 2.5Mg Tab, Drug: Palbociclib 125mgPatients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Female ≥ 18 years of age pre and post-menopausal
- Oligometastatic disease (≤ 5 sites of disease)
- Premenopausal status is defined as either:
- Patient had last menstrual period within the last 12 months, OR
- If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR
Key exclusion criteria (12 listed)
- Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
- Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy
- Male breast cancer patients
- Any lesion >5 cm in greatest diameter.
- Inability to obtain histologic proof of metastatic breast cancer
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions)Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. They will undergo tumor Immunogenic-SBRT(I-SBRT) days 1-12 (+/-2 days, to enable inclusion of holidays). During the week preceding day 1, they will undergo simulation and planning for radiotherapy. Each oligometastatic lesion will be treated with I-SBRT every 48 hours. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions | Radiation | ARM 2 - Letrozole and Palbociclib + I-SBRT |
| Letrozole 2.5Mg TabAll patients start standard therapy with oral letrozole (Femara), day 1 of the study. | Drug | ARM 1 - Letrozole and Palbociclib, ARM 2 - Letrozole and Palbociclib + I-SBRT |
| Palbociclib 125mgPatients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. | Drug | ARM 1 - Letrozole and Palbociclib, ARM 2 - Letrozole and Palbociclib + I-SBRT |
Primary outcome
Number of subjects achieving Objective response rate (ORR) will be assessed.
Time frame: End of study, up to 36 months.
ORR is defined as the percentage of subjects with either a confirmed complete response (CR) or partial response (PR).
Number of Subjects achieving Progression free survival (PFS)
Time frame: End of study, up to 36 months.
Progression free survival (PFS) is defined as the time from the start of study treatment until the disease progression or death.
Number of subjects achieving Overall survival(OS) will be assessed.
Time frame: End of study, up to 36 months.
OS is defined as the time from the start of treatment until death.
2 secondary outcomes
Serial levels of Circulating tumor DNA (ctDNA)
Time frame: End of study, up to 36 months.
Circulating tumor DNA (ctDNA) levels
Time frame: End of study, up to 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 21 Sep 2020.
- 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.
Silvia Formenti, M.D. principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab and Palbociclib 125mg in people with Breast Cancer, run by Weill Medical College of Cornell University.
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 19 inclusion and 12 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of subjects achieving Objective response rate (ORR) will be assessed. (time frame: End of study, up to 36 months.). The study lists 3 primary outcomes in all. 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 21 Sep 2020.