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THP shows noninferior pCR rates compared to TCbHP in HER2-positive invasive breast cancerTrial shows omitting carboplatin maintains success in breast cancer

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Key Takeaway
Note that omitting carboplatin (THP) maintains noninferior pCR rates while reducing Grade 3 and 4 adverse events.

This Phase III randomized controlled trial enrolled 774 women aged 18 years or older with previously untreated, stage II and III, HER2-positive invasive breast cancer. The study compared THP (investigator-selected taxane plus trastuzumab and pertuzumab without carboplatin) to TCbHP (investigator-selected taxane plus trastuzumab and pertuzumab with carboplatin).

The primary outcome was the pathologic complete response (pCR) rate in the breast and axilla. The THP group achieved a pCR rate of 64.1% (245 patients), while the TCbHP group achieved 65.9% (253 patients). The absolute difference was -1.8% with a 95% CI of -8.5 to 5.0, and an odds ratio of 0.93 (95% CI: 0.69 to 1.25; p = 0.0089), supporting noninferiority.

Regarding safety, the THP group showed improved tolerability compared to TCbHP. Grade 3 and 4 adverse events occurred in 20.7% of the THP group versus 34.6% of the TCbHP group. Specific differences included neutropenia (6.8% vs 16.4%), leukopenia (5.5% vs 14.8%), and diarrhea (2.6% vs 4.2%). Serious adverse events were lower in the THP group (1.3% vs 4.7%).

Omitting carboplatin may be a viable clinical option for HER2-positive breast cancer patients to reduce toxicity while maintaining comparable pCR rates.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in the management of HER2-positive invasive breast cancer by evaluating the necessity of carboplatin. While previous coverage included chemo-immunotherapy for rare triple-negative neuroendocrine breast cancer, this trial specifically evaluates the impact of omitting carboplatin on pCR rates and safety in the HER2-positive population.

When treating HER2-positive invasive breast cancer, doctors often use a combination of drugs to shrink tumors. One common ingredient in these combinations is carboplatin. A large study involving 766 women looked at whether removing this specific drug would change the effectiveness of the treatment or impact patient safety.

The results showed that patients who did not receive carboplatin had nearly identical success rates compared to those who did. Specifically, about 64% of patients in the group without carboplatin achieved a pathologic complete response, while 65.9% of those with it reached the same goal. This means the primary treatment remained highly effective even when one component was removed.

However, there was a significant difference in how well patients tolerated the treatment. Those who did not receive carboplatin experienced much lower rates of severe side effects, such as low white blood cell counts and diarrhea. Serious adverse events were also notably lower in that group. While both treatments worked well to fight the cancer, the version without carboplatin was found to be easier for patients to tolerate.

What this means for you:
Removing carboplatin from certain breast cancer treatments can reduce severe side effects while maintaining high success rates.

Common questions

Is it safe to skip the carboplatin drug?

The study suggests that omitting carboplatin is a viable option. Patients who did not receive carboplatin had fewer severe side effects, such as neutropenia (low white blood cells) and diarrhea, compared to those who did receive it.

Does removing carboplatin make the treatment less effective?

No. The trial showed that both groups had very similar success rates. One group achieved a 64.1% complete response rate, while the other reached 65.9%. This indicates the treatment remains effective without the extra drug.

What are the specific side effects of these treatments?

Patients receiving carboplatin had higher rates of severe issues like leukopenia and diarrhea. Specifically, those not receiving carboplatin saw lower rates of neutropenia (6.8% vs 16.4%) and fewer serious adverse events overall.

Study Details

Study typeRct
Sample sizen = 774
EvidenceLevel 2
Follow-up216.0 mo
PublishedJun 2026
View Original Abstract ↓
PURPOSE: The neoCARHP aimed to investigate the efficacy and safety of investigator-selected taxane (docetaxel, paclitaxel, or nab-paclitaxel) plus trastuzumab and pertuzumab, with carboplatin (TCbHP) or without carboplatin (THP), in stage II and III human epidermal growth factor receptor 2 (HER2)-positive breast cancer. METHODS: The neoCARHP was a multicenter, randomized, phase III, noninferiority study. Eligible patients were women age 18 years or older with previously untreated, stage II and III, HER2-positive invasive breast cancer. Patients were randomly assigned (1:1) to receive six 3-week cycles of TCbHP or THP. The primary end point was pathologic complete response (pCR) rate in the breast and axilla (ypT0/is ypN0) in the modified intention-to-treat (mITT) population (all randomly assigned patients receiving at least one dose of study treatment). Safety was evaluated in all patients who received any study treatment. RESULTS: Between April 30, 2021, and August 27, 2024, 774 patients were randomly assigned and 766 were included in the mITT population (382 in THP and 384 in TCbHP). pCR was achieved in 245 (64.1% [95% CI, 59.1 to 69.0]) patients in the THP group and 253 (65.9% [60.9-70.6]) in the TCbHP group (absolute difference, -1.8% [95% CI, -8.5 to 5.0]; odds ratio, 0.93 [95% CI, 0.69 to 1.25]; = .0089). The THP group had fewer grade 3 and 4 adverse events (20.7% 34.6%) and serious adverse events (1.3% 4.7%) than the TCbHP group. The most common grade 3 and 4 adverse events with THP were neutropenia (6.8% 16.4% with TCbHP), leukopenia (5.5% 14.8%), and diarrhea (2.6% 4.2%). No treatment-associated deaths occurred. CONCLUSION: THP provided noninferior pCR rates and improved tolerability compared with TCbHP. Omitting carboplatin may be applicable in HER2-positive breast cancer.
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