November 29, 2021

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ESMO 2021: 3 important clinical trials in Breast Cancer Conference

ESMO 2021: 3 important clinical trials in Breast Cancer Conference

ESMO 2021: 3 important clinical trials in Breast Cancer Conference


ESMO 2021: 3 important clinical trials in Breast Cancer Conference.  Affected by the epidemic, this year’s ESMO Breast Cancer Conference was held online from May 5th to 8th. The full collection of abstracts published on May 5th at this ESMO Breast Cancer Conference contains a total of 179 abstracts. This article will present some abstract research results for readers.


01. KAITLIN Phase III clinical study: AC-KP vs AC-THP in the treatment of high-risk HER-2 positive early breast cancer (no.420)

The KAITLIN Phase III clinical trial analyzed the trastuzumab-maytansin conjugate (TDM-1; K) + Pertuzumab (P) regimen in HER-2 positive high-risk early breast cancer patients (n = 918) Invasive disease-free survival (IDFS) and biomarkers that may be related to the response of the regimen of trastuzumab (H) + paclitaxel (T) + P (n = 928) The relationship between.

The results showed that there was no significant difference in survival benefit between the two groups of patients with the same baseline, and none of them reduced the risk of IDFS events. Biomarkers such as HER2 mRNA, PTEN expression, and HER2 gene copy have no significant relationship with the patient’s prognosis.

Clinical trial information: NCT01966471
Original: O. Metzger, C. Lambertini, I. Krop, et al. Biomarker analysis from KAITLIN, a randomised phase III study of adjuvant trastuzumab emtansine (TDM-1; K) plus pertuzumab (P) versus trastuzumab (H) tax plusane (T) plus P after anthracyclines (AC) for high-risk HER2-positive early breast cancer (EBC). Annals of Oncology (2021) 32 (suppl_2): S37-S47. 10.1016/annonc/annonc504



02. ShortHER randomized trial: 9 weeks vs 1 year long-term follow-up results of adjuvant trastuzumab therapy (no. 410)

The ShortHER trial randomly divided 1254 patients with HER2+ early breast cancer into a 9-week treatment group with chemotherapy and trastuzumab and a 1-year treatment group with chemotherapy and trastuzumab. This study is designed as a non-inferiority trial (a clinical trial that shows that the efficacy of the test drug is not inferior to the positive control drug through a controlled trial), and the DFS hazard ratio (HR) <1.29 is the non-inferiority limit.

In the study, the overall survival rate (the common primary endpoint of the study) and the updated DFS curve were reported according to the long-term and short-term risk categories.

With a median follow-up of 8.7 years, a total of 237 DFS events occurred: 121 cases in the short treatment period and 116 cases in the long treatment period (HR 1.09; 90% confidence interval 0.88-1.35).

The DFS divided by postoperative risk group is: low risk (pT<2 cm and pN0) accounted for 37.2% of the study population, HR 0.91 (90%CI 0.60~1.38); medium risk (pT<2 cm and 1~3 pN+ Or pT>2 cm and 0~3 pN+) accounted for 46.7% of the study population HR 0.88 (90%CI 0.63~1.21); high-risk groups (any pT and 4+pN+) accounted for 15.2% of the study population, HR 2.06 (90% CI 1.36~3.1). 109 deaths have been reported (58 in the short treatment period and 51 in the long treatment period). The short treatment period group of 9 years OS accounted for 90%, and the long treatment period group accounted for 91% (hr1.18; 90% confidence interval 0.86 to 1.62).

Through the dynamic DFS and OS analysis of the short treatment period group trial, it was confirmed that the 9-week adjuvant trastuzumab treatment had a good long-term effect on patients with low and medium risk factors. Such patients accounted for 83.9% of the ShortHER study, and most received conventional treatment. Trastuzumab treatment for one year is still the standard treatment.

According to the results of this study, it is suggested that if the opportunity to obtain trastuzumab is limited, a shorter trastuzumab treatment cycle can be selected.

Clinical trial information: EUDRACT: 2007-004326-25; NCI: NCT00629278.
Original: PF Conte, A. Frassoldati, G. Bisagni, et al. Nine weeks vs 1-year adjuvant trastuzumab: Long term outcomes of the ShortHER randomised trial. Annals of Oncology (2021) 32 (suppl_2): S37-S47. 10.1016 /annonc/annonc504



03. BERENICE trial: 5-year follow-up outcome of pertuzumab/trastuzumab in the treatment of early HER2-positive breast cancer (no. 430)

BERENICE is a multi-center, open-label, non-comparative phase II trial to evaluate the cardiac safety of neoadjuvant pertuzumab / trastuzumab (PH) combined with anthracycline-containing chemotherapeutics (main purpose).

This study reports the 5-year results at the end of the study (clinical deadline: August 25, 2020), including additional safety and efficacy data (secondary goals).

Patients with HER2-positive breast cancer with stage Ⅱa to Ⅲ and left ventricular ejection fraction (LVEF) ≥ 55% were assigned to group A according to the doctor’s selection (dose-dense adriamycin/cyclophosphamide chemotherapy, administered once every 2 weeks x 4 cycles) → paclitaxel once a week x 12 cycles) or group B (5-fluorouracil, epirubicin, cyclophosphamide, once every 3 weeks x 4 cycles) → docetaxel every 3 Dosing once a week x 4 cycles. PH is administered once every 3 weeks, starting from the use of taxanes and continuing until after the operation, a total of 17 cycles.

The 199 patients in group A and 201 patients in group B were followed up for an average of 64.5 months. The results showed that no new cardiac safety problems were found. There were few events during the treatment-free period. The incidence of grade III/IV congestive heart failure was higher. low.

The 5-year event-free survival (EFS) rates of group A and group B were 90.8% (95% CI, 86.5-95.2) and 89.2% (84.8-93.6), respectively. The 5-year overall survival rates of group A and group B were 96.1% (93.3-98.9) and 93.8% (90.3-97.2), respectively. According to the PAM 50 classification, most of the 339 patients had HER2-enriched (ER-/PR- subtype) tumors (51.6%), the 5-year EFS rate of group A was 93.1% (87.2-98.9), group B It was 88.3% (81.8-94.8).

The final results of BERENICE showed continuous cardiac safety and good long-term efficacy results, further supporting the neoadjuvant/adjuvant PH combined with standard therapies containing anthracyclines for the treatment of early HER2-positive breast cancer patients.

Clinical trial information: NCT02132949 (WO29217)
Original: C. Dang, MS Ewer, S. Delaloge, et al. Pertuzumab/trastuzumab in early stage HER2-positive breast cancer: 5-year and final analysis of the BERENICE trial. Annals of Oncology (2021) 32 (suppl_2): S37-S47. 10.1016/annonc/annonc504




(source:internet, reference only)

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