Vaccination of Triple Negative Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02938442|
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : March 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer Breast Neoplasms||Biological: P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel Drug: Doxorubicin + Cyclophosphamide + Paclitaxel||Phase 1 Phase 2|
The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER) negative, progesterone receptor (PR) negative and HER2-negative (= triple negative - TN) breast cancer. P10s-PADRE will be administered with MONTANIDE™ ISA 51 VG as adjuvant. Human breast cancers that express Tumor Associated Carbohydrate Antigens (TACAs) can be immunogenic, and enhancing the anti-TACA antibodies and immune effector function already present may augment the cytotoxic effects of standard therapies.
A randomized two-arm, open-label, multi-center phase II trial is designed with the goal being to evaluate the efficacy of combining vaccination of the P10s-PADRE formulation with neoadjuvant chemotherapy. Patients will be randomly assigned in a 2:1 ratio to standard chemotherapy plus P10s-PADRE or to standard chemotherapy alone. Efficacy will be based on the rate of pathologic Complete Response (pCR) observed among TN breast-cancer patients treated with the combination as compared with the group of patients who receive standard chemotherapy alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Combined Phase i/II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG STERILE Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer|
|Actual Study Start Date :||January 25, 2019|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2024|
Active Comparator: Control Arm
Subjects randomized to the control arm will receive SoC neoadjuvant chemotherapy starting on week 1. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Drug: Doxorubicin + Cyclophosphamide + Paclitaxel
Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
Other Name: Standard neoadjuvant chemotherapy
Experimental: Chemo+Vaccine Arm
Subjects randomized to the chemo+vaccine arm will be immunized with P10s-PADRE in MONTANIDE™ ISA 51 VG a total of three times. The vaccine will be administered on weeks 1, 2 and 3 prior to chemotherapy. Then, they will start their SoC neoadjuvant chemotherapy on week 4. Doxorubicin and cyclophosphamide (AC) will be administered concurrently every two weeks for four cycles with pegfilgrastim (or equivalent growth factor) on day 2 of each AC cycle, followed by paclitaxel weekly x 12 weeks.
Biological: P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel
Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
Other Name: P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard neoadjuvant chemotherapy
- Safety/tolerability [ Time Frame: At the time of definitive surgery (4-8 weeks after chemo); between Week 20 and Week 23 ]Monitor the safety and tolerability of the investigational product, P10s-PADRE in MONTANIDETM ISA 51 VG, when it is administered in combination with SoC Neoadjuvant chemotherapy.
- Demonstration of clinical response [ Time Frame: [Time Frame: Week 70 (±4 weeks) per subject] ]Determine if the Chemo+vaccine regimen in TNBC would lead to a significantly higher rate of pCR in breast and axillary nodes at time of definitive surgery compared to the pCR rate of 40% expected on the control arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938442
|Contact: Sindhu Malapati, MDfirstname.lastname@example.org|
|Contact: Aaron Holleyemail@example.com|
|United States, Arkansas|
|Highlands Oncology Group||Not yet recruiting|
|Fayetteville, Arkansas, United States, 72703|
|Contact: J T Beck, MD|
|Principal Investigator: J T Beck, MD|
|University of Arkansas for Medical Sciences||Recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Sindhu Malapati, MD 501-686-8274 MalapatiSindhu@uams.edu|
|Contact: Aaron Holley 5016868274 firstname.lastname@example.org|
|Principal Investigator: Sindhu Malapati, MD|
|Principal Investigator:||Sindhu Malapati, MD||University of Arkansas|