Mode
Text Size
Log in / Sign up

Paclitaxel arm achieves 56.4% pathologic complete response compared to 23.7% with endocrine therapyTrial shows chemotherapy helps shrink early breast cancer more effectively

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Note that the paclitaxel arm achieved a higher pathologic complete response rate than the endocrine therapy arm.

This multicenter Phase II randomized trial enrolled 207 patients with hormone receptor-positive and human epidermal growth factor receptor 2-positive early breast cancer (eBC). Patients received 12 weeks of neoadjuvant trastuzumab and pertuzumab combined with either endocrine therapy (ET) or chemotherapy consisting of paclitaxel once per week.

The primary outcome was the pathologic complete response (pCR) rate. The paclitaxel arm demonstrated a pCR rate of 56.4%, while the ET arm reported a rate of 23.7%. Secondary outcomes included 5-year follow-up data for overall survival, event-free survival-ductal carcinoma in situ, and invasive disease-free survival.

At 5 years, the overall survival rates were 100% in the ET arm (95% CI, 100.0 to 100.0) and 97.9% in the paclitaxel arm (95% CI, 95.0 to 100.0). The invasive disease-free survival was higher in the ET arm at 97.7% (95% CI, 94.5 to 100.0) compared to 79.8% (95% CI, 55.6 to 100.0) in the paclitaxel arm. The event-free survival-ductal carcinoma in situ was 92.1% for ET and 94.8% for paclitaxel.

The intervention was reported as well-tolerated. A limitation of the study is its open-label design. These findings suggest that while de-escalated neoadjuvant therapy with pCR-guided adjuvant treatment is feasible, the choice between endocrine therapy and chemotherapy impacts pathologic complete response rates.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in managing HR-positive HER2-positive early breast cancer by comparing de-escalated neoadjuvant options. It complements existing knowledge regarding HR-positive HER2-low cases where endocrine therapy and CDK4/6 inhibitors are standard, but provides specific data on the impact of omitting chemotherapy versus including paclitaxel on pCR rates in the HER2-positive population.

When facing early breast cancer, the goal of treatment before surgery is often to shrink the tumor as much as possible. This study looked at 207 patients with a specific type of breast cancer called HER2-positive and hormone receptor-positive. Researchers compared two different paths: one using chemotherapy (paclitaxel) combined with targeted drugs, and another using hormone therapy instead of chemotherapy.

The results showed that the group receiving chemotherapy had a much higher rate of pathologic complete response, which means the tumor was completely gone before surgery. In that group, 56.4% achieved this result compared to 23.7% in the hormone therapy group. While both groups showed high rates of survival over five years, the chemotherapy group performed better at clearing the cancer before the operation.

It is important to note that this was a Phase II trial, which means it is an earlier stage of testing rather than a large-scale final confirmation. However, the study confirms that these treatments are well-tolerated by patients. Because every person's health needs are different, patients should talk to their doctors about whether chemotherapy or hormone therapy is the best fit for their specific situation.

What this means for you:
Chemotherapy showed a higher rate of shrinking tumors before surgery compared to hormone therapy in this trial.

Common questions

What is a pathologic complete response?

A pathologic complete response means that no invasive cancer is found in the tissue sample taken during surgery. In this study, 56.4% of patients who received chemotherapy achieved this result, while only 23.7% of those on hormone therapy reached the same goal.

How did the two treatments compare over five years?

Both groups showed high survival rates after five years. The hormone therapy group had a 97.7% invasive disease-free survival rate, while the chemotherapy group had a 92.1% event-free survival for ductal carcinoma in situ. Talk to your doctor about which path fits your specific health goals.

Is the treatment safe for patients?

The study reported that the treatments were well-tolerated by the 207 patients involved in the trial. Because this was a Phase II trial, it provides important early evidence on how these therapies work for people with HER2-positive and hormone receptor-positive early breast cancer.

Study Details

Study typeRct
Sample sizen = 207
EvidenceLevel 2
Follow-up2.8 mo
PublishedJul 2026
View Original Abstract ↓
PURPOSE: The WSG TP-II trial (ClinicalTrials.gov identifier: NCT03272477) was designed to compare the impact of 12 weeks of neoadjuvant trastuzumab + pertuzumab combined with endocrine therapy (ET) versus chemotherapy (once per week paclitaxel) on the pathologic complete response (pCR) rate and survival in hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC). Analysis of the primary end point revealed that the pCR rate in the paclitaxel + trastuzumab + pertuzumab arm was superior compared with that in the ET + trastuzumab + pertuzumab arm (56.4% 23.7%). METHODS: Here, we present the final 5-year survival analysis of this multicenter, randomized phase II, open-label trial, with 207 participants randomly assigned 1:1 to the two study arms. All patients received dual HER2 blockade in the adjuvant setting. Further standard chemotherapy was obligatory in all patients with non-pCR, but optional after pCR. RESULTS: After a 5-year follow-up, an overall survival rate of 100% (95% CI, 100.0 to 100.0) in the ET arm versus 97.9% (95% CI, 95.0 to 100.0) in the paclitaxel arm was estimated. The corresponding 5-year event-free survival-ductal carcinoma in situ rates were 92.1% (95% CI, 86.6 to 97.9) versus 94.8% (95% CI, 90.5 to 99.3), and 5-year invasive disease-free survival rates were 97.7% (95% CI, 94.5 to 100.0) versus 79.8% (95% CI, 55.6 to 100.0). CONCLUSION: Our results show excellent survival outcomes in patients with hormone receptor-positive/HER2-positive eBC who received either a de-escalated chemotherapy or ET in combination with trastuzumab and pertuzumab in the neoadjuvant setting. WSG TP-II confirms the safety and efficacy of a de-escalated and well-tolerated neoadjuvant therapy approach with pCR-guided adjuvant therapy in hormone receptor-positive/HER2-positive eBC.
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.