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Alkylating agents

Pembrolizumab for Breast Cancer (TN-IBC Trial)

Phase 2
Waitlist Available
Led By Paula R Pohlmann, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Summary

This trial is testing whether a combination of immunotherapy and chemotherapy drugs can shrink tumors in patients with stage III-IV triple negative breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The ( pCR ) rate pathological complete response, defined as the absence of invasive carcinoma in the breast and the lymph nodes.

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (panitumumab,pembrolizumab,neoajuvant chemotherapy)Experimental Treatment6 Interventions
CYCLES 1-4: Patients receive pembrolizumab IV over 30 minutes and panitumumab IV over 30-60 minutes on day 1 of cycle 0. Cycle 0 continues for 7 days in the absence of disease progression or unacceptable toxicity. Patients then receive panitumumab IV over 30-60 minutes on days 1, 8, and 15 of cycles 1-3 and days 1 and 8 of cycle 4, pembrolizumab IV over 30 minutes on day 1 of cycles 2-4, paclitaxel IV over 1-3 hours on days 1, 8, and 15 of cycles 1-4, and carboplatin IV over 30 minutes on day 1, 8 and 15 of cycles 1-4. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5-8: Patients receive standard of care treatment, including pembrolizumab IV over 30 minutes, doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panitumumab
2017
Completed Phase 3
~7140
Cyclophosphamide
1995
Completed Phase 3
~3770
Carboplatin
2014
Completed Phase 3
~6670
Doxorubicin
2012
Completed Phase 3
~7940
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,279 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,401 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Paula R Pohlmann, MDPrincipal InvestigatorM.D. Anderson Cancer Center
~0 spots leftby Jul 2025
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