Neoadjuvant THP vs TCHP for Breast Cancer
(NeoTHERa Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare two treatment combinations to determine which is more effective for early-stage HER2-positive breast cancer. Participants will receive either a combination of carboplatin and docetaxel, along with trastuzumab and pertuzumab, or docetaxel with trastuzumab and pertuzumab. The goal is to identify which treatment better shrinks the cancer before surgery. Individuals diagnosed with HER2-positive breast cancer who have not received prior treatments might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study raised safety concerns with the combination of Carboplatin, Docetaxel, Trastuzumab, and Pertuzumab. About 24% of patients experienced serious side effects, including low blood cell counts, diarrhea, and nerve pain. Notably, there were no reports of heart problems, which are crucial to monitor with these drugs. Another study found this treatment effective in shrinking tumors without causing heart issues.
Research indicates that the treatment using Docetaxel, Trastuzumab, and Pertuzumab is generally well-tolerated. Some patients experienced serious side effects like low blood counts and diarrhea, but these were manageable. No major heart problems were reported in the studies reviewed.
Both treatment options have shown positive results in other studies, but side effects can occur. Anyone considering joining a trial should discuss these risks and benefits with their doctor.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments in this trial for breast cancer because they explore different combinations of chemotherapy and targeted therapies. Arm A combines carboplatin and docetaxel with trastuzumab and pertuzumab, aiming to enhance the effectiveness of treatment by adding carboplatin, which could improve outcomes by damaging cancer cells' DNA. Arm B, on the other hand, focuses on docetaxel with trastuzumab and pertuzumab, aiming to discover if this combination can maintain effectiveness while potentially reducing side effects compared to adding carboplatin. These approaches may offer more tailored and potentially less toxic treatment options compared to traditional chemotherapy regimens, enhancing the precision of breast cancer therapy.
What evidence suggests that this trial's treatments could be effective for early breast cancer?
This trial will compare two treatment regimens for HER2-positive breast cancer. Participants in Arm A will receive a combination of four drugs: carboplatin, docetaxel, trastuzumab, and pertuzumab (TCHP). Research has shown that this combination leads to a 64% chance of the cancer becoming undetectable after treatment, with 90% of patients not experiencing cancer growth for three years. Participants in Arm B will receive a combination of three drugs: docetaxel, trastuzumab, and pertuzumab (THP). Studies report an 85.3% overall response rate for this combination, with some patients achieving complete cancer disappearance and a 34% reduction in the risk of death. Both treatments show promising results in shrinking cancer and improving survival chances.23678
Who Is on the Research Team?
Yiduo Hu, MD
Principal Investigator
University of Kansas Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neoadjuvant regimens (Docetaxel+Carboplatin+Herceptin/Perjeta or Docetaxel+Herceptin/Perjeta) every 21 days for 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of recurrence-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Docetaxel
- Pertuzumab
- Trastuzumab
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Docetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.
Carboplatin and docetaxel plus trastuzumab and pertuzumab every 21 days for 6 cycles. Doses and route of administration per institutional standards.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
Citations
Pertuzumab/Docetaxel/Carboplatin/Trastuzumab Regimen ...
Data from patients treated with neoadjuvant PTCH between January 2015 and December 2024 were retrospectively reviewed.
Real World Evidence of Neoadjuvant Docetaxel/Carboplatin ...
Neoadjuvant TCHP therapy had a pCR rate of 64% and a 3-year event-free survival of 90% in real world experience.
NCT02003209 | Docetaxel, Carboplatin, Trastuzumab, and ...
This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work
Neoadjuvant Chemotherapy with Docetaxel, Carboplatin and ...
Data from adjuvant trials have shown that the combination of docetaxel, carboplatin and weekly trastuzumab (TCH) is well tolerated and as effective as ...
a multicentre, randomised, phase 3 trial
We aimed to evaluate the efficacy of weekly nab-paclitaxel compared with the standard regimen of docetaxel plus carboplatin, both with ...
Retrospective study of the efficacy and safety of neoadjuvant ...
Retrospective study of the efficacy and safety of neoadjuvant docetaxel, carboplatin, trastuzumab/pertuzumab (TCH-P) in nonmetastatic HER2-positive breast ...
Pertuzumab, Trastuzumab, and Docetaxel in HER2 ...
First-line therapy with pertuzumab, trastuzumab, and docetaxel significantly improved overall survival among patients with HER2-positive ...
Efficacy and Safety of Dual Anti-HER2 Blockade and ... - PMC
The incidence of grade 3 or higher toxicity in the docetaxel + carboplatin + trastuzumab + pertuzumab group was significantly higher than that ...
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