Combined Immunotherapies in Metastatic ER+ Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04563507
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Tab — DRUG
    All patients start standard therapy with oral letrozole (Femara), day 1 of the study.
  • Palbociclib 125mg — DRUG
    Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.

Study Details

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.

Key Dates

Start date
Nov 12, 2020
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ARM 1 - Letrozole and Palbociclib
    Patients randomized to arm 1 will start standard Letrozole followed by Palbociclib at day 21.
  • Active Comparator: ARM 2 - Letrozole and Palbociclib + I-SBRT
    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.

Primary Outcome Measure

Progression free survival (PFS) will be measured [ Time Frame: End of study, up to 36 months. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brooklyn Methodist Hospital - NewYork PresbyterianNew YorkNew York11215
Izael Niño, M.S.
[email protected]
929 470 9426
Hani Ashamalla, M.D. (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital - QueensNew YorkNew York11355
Hina Ali, M.D.
[email protected]
Akkamma Ravi, M.D. (SUB_INVESTIGATOR)
Silvia Formenti, M.D. (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Fabiana Gregucci, M.D.
[email protected]
6469623110
Silvia Formenti, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brooklyn Methodist Hospital - NewYork Presbyterian· New York, NYNew York Presbyterian Hospital - Queens· New York, NYWeill Cornell Medicine· New York, NY

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