Recruiting
Phase 2

Neoadjuvant Therapy

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06245889

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paclitaxel

Carboplatin

Pembrolizumab

Doxorubicin

Cyclophosphamide

Study Details

Brief 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).

Conditions

Triple Negative Breast Cancer

Study ID

NCT06245889

Start date

May 1, 2024

Status verified date

Sep, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neoadjuvant therapy

4 cycles of paclitaxel/carboplatin/pembrolizumab

Interventions

Paclitaxel

chemotherapy

Carboplatin

chemotherapy

Pembrolizumab

immunotherapy

Doxorubicin

additional chemotherapy - neoadjuvant or adjuvant rescue

Cyclophosphamide

additional chemotherapy - adjuvant rescue

Olaparib

adjuvant rescue

Capecitabine

adjuvant rescue

Primary outcome measure

  • SULmax in relation to pCR [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Cesar A Santa-Maria, M.D.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • breast cancer
  • triple negative
  • neoadjuvant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-09-03.