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Trial Title:
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
NCT ID:
NCT06245889
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Cyclophosphamide
Carboplatin
Pembrolizumab
Doxorubicin
Capecitabine
Olaparib
Conditions: Keywords:
breast cancer
triple negative
neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Eligible patients with stage 2 and 3 TNBC (ER<10% eligible) will be treated with 4 cycles
of paclitaxel/carboplatin/pembrolizumab prior to surgery. A PET scan will be performed at
baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment
completion. Patients with complete clinical response will proceed to surgery. Patients
with RD will complete neoadjuvant rescue with 4 cycles of doxorubicin/cyclophosphamide
prior to surgery. If residual disease identified after surgery, adjuvant therapy to be
determined by the treating oncologist (may include
doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
chemotherapy
Arm group label:
Neoadjuvant therapy
Other name:
Taxol
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
chemotherapy
Arm group label:
Neoadjuvant therapy
Other name:
Paraplatin
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
immunotherapy
Arm group label:
Neoadjuvant therapy
Other name:
Keytruda
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
additional chemotherapy - neoadjuvant or adjuvant rescue
Arm group label:
Neoadjuvant therapy
Other name:
Adriamycin
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
additional chemotherapy - adjuvant rescue
Arm group label:
Neoadjuvant therapy
Other name:
Cytoxan
Intervention type:
Drug
Intervention name:
Olaparib
Description:
adjuvant rescue
Arm group label:
Neoadjuvant therapy
Other name:
Lynparza
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
adjuvant rescue
Arm group label:
Neoadjuvant therapy
Other name:
Xeloda
Summary:
Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4
cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed
at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment
completion. Patients with complete clinical response will proceed to surgery. Patients
with clinical residual disease will complete neoadjuvant rescue with 4 cycles of
doxorubicin/cyclophosphamide prior to surgery. If residual disease identified after
surgery, adjuvant therapy to be determined by the treating oncologist (may include
doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc).
Detailed description:
Eligible participants will undergo baseline procedures including research bloodwork, MRI
and PET scan. Participants will then be treated with one cycle of paclitaxel, carboplatin
and pembrolizumab (TCarbo/pembro). At the end of Cycle one patients will undergo repeat
procedures (bloodwork and PET scan), and then continue with treatment for an additional
three cycles. ctDNA will be collected on day 1 of each cycle. At the end of treatment
patients will undergo repeat MRI.
Patients achieving a clinical complete response (CR) on MRI will proceed with surgery.
Patients with clinical residual disease (RD) on MRI will be recommended a biopsy, and be
recommended "rescue" neoadjuvant doxorubicin and cyclophosphamide with pembrolizumab
(AC/pembro) for four additional cycles, and then proceed with surgery. Note:
patients/treating physician may opt to proceed with surgery.
Archival tissue will be collected from the surgical product. Patients achieving a
pathologic CR (pCR) may proceed with adjuvant pembrolizumab per standard of care, and
treating physician's discretion. Patients with pathological RD may proceed with "rescue"
adjuvant AC/pembrolizumab for four additional cycles (if not given neoadjuvantly), per
treating physician discretion. The participants may also receive Aadjuvant capecitabine
or olaparib as indicated and per treating physician's discretion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and
including 10% is eligible
2. Age ≥ 18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. Eligible for standard chemo-immunotherapy as determined by treating physician,
including consideration of:
1. Adequate marrow and organ function
2. Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as
uncontrolled autoimmune disease, or the use of immunosuppressive medications)
5. Patients must have the ability to understand and the willingness to sign a written
informed consent prior to registration on study
Exclusion Criteria:
1. Patients unable to undergo PET or MRI
2. Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest
wall recurrence)
3. Inflammatory breast cancer
4. Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hopkins Breast Trials
Phone:
410-614-1361
Email:
HopkinsBreastTrials@jhmi.edu
Investigator:
Last name:
Cesar A Santa-Maria, M.D.
Email:
Principal Investigator
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
JHCCCRO
Phone:
410-955-8866
Email:
jhcccro@jhmi.edu
Start date:
May 1, 2024
Completion date:
June 2030
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Collaborator:
Agency:
Breast Cancer Research Foundation
Agency class:
Other
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06245889
