Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting.

Background: The TROIKA trial established that HD201 and trastuzumab were equivalent in terms of primary endpoints (total pathological complete response) following neoadjuvant treatment. The objective of the present analysis was to compare survival outcomes and final safety.

Methods: In the TROIKA trial, patients with ERBB2-positive early breast cancer were randomized and treated with either HD201 or the referent trastuzumab.

Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial.

Importance: The drug HD201 is a biosimilar candidate for breast cancer treatment as the reference trastuzumab.

Objective: To compare the efficacy of HD201 with referent trastuzumab.

Design, Setting, And Participants: This randomized clinical trial (TROIKA) included 502 women with ERBB2-positive early breast cancer treated with either HD201 or referent trastuzumab.

Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial.

Purpose: Equivalent efficacy was demonstrated for the biosimilar CT-P6 and trastuzumab following neoadjuvant therapy for patients with human epidermal growth factor receptor-2 (HER2)-positive early breast cancer. Following adjuvant treatment, efficacy and safety were comparable between treatments. We report updated safety and efficacy data after up to 3 years' follow-up.

Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial.

Purpose: Neoadjuvant CT-P6, a trastuzumab biosimilar, demonstrated equivalent efficacy to reference trastuzumab in a phase 3 trial of HER2-positive early-stage breast cancer (EBC) (NCT02162667). We report post hoc analyses evaluating pathological complete response (pCR) and breast pCR alongside additional efficacy and safety measures.

Methods: Following neoadjuvant treatment and surgery, patients received adjuvant CT-P6 or trastuzumab (6 mg/kg) every 3 weeks for ≤ 1 year.

CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial.

Background: CT-P6 is a proposed biosimilar to reference trastuzumab. In this study, we aimed to establish equivalence of CT-P6 to reference trastuzumab in neoadjuvant treatment of HER2-positive early-stage breast cancer.

Methods: In this randomised, double-blind, active-controlled, phase 3 equivalence trial, we recruited women aged 18 years or older with stage I-IIIa operable HER2-positive breast cancer from 112 centres in 23 countries.

Histopathological characterization of ulcerated breast cancer and comparison to their non-ulcerated counterparts.

Approximately 6-15 % of breast cancer patients are diagnosed with primary ulcerated breast cancer (ULBC). ULBC is known to be associated with short recurrence free and poor overall survival. Therefore, the purpose of this study was to characterize ULBC and compare the histopathological findings with those of non-ulcerative breast cancer (NULBC).

[Unpleasant smell from a mouth--halitosis].

Halitosis--unpleasant smell from a mouth is widely spread pathology. Approximately one-fourth of world's population is suffering from this disease. Appearance of Halitosis is related not only with dental problems, but also with somatic disease.

Effects of fulvestrant 250mg in premenopausal women with oestrogen receptor-positive primary breast cancer.

Fulvestrant (Faslodex) reduces markers of hormone sensitivity and proliferation in postmenopausal women. This Phase II double-blind, randomised, multicentre study compared the effects of a single 250mg intramuscular dose of fulvestrant and placebo 14-21 days prior to surgery of curative intent on the oestrogen receptor (ER), progesterone receptor and Ki67 levels in 66 premenopausal women with ER-positive primary breast cancer. There were no statistically significant differences between fulvestrant and placebo with respect to any of the three markers analysed.

[Efficiency of lymphatic mapping by intradermal injection of vital blue dye for sentinel node identification in T1-2 N0-1 M0 stage breast cancer patients].

The lymphatic mapping and sentinel lymphadenectomy procedure is a highly accurate method of axillary staging in breast cancer. Because no other method accurately predicts axillary node status without complete axillary dissection, this technique has a potential to become the standard method of axillary staging for breast cancer in near future. The aim of the study was to evaluate efficiency of lymphatic mapping by intradermal injection of vital blue dye for sentinel node identification in T(1-2) N(0-1) M(0) stage breast cancer patients.

[Sentinel nodes identification efficacy prognostic criteria in breast cancer].

The sentinel node concept assumes that a malignancy that metastasizes by the lymphatic route will initially travel to one or a few lymph node(s). Although a tumor may disseminate to other nodes, it will remain in the sentinel node, and therefore the status of the entire basin is predicted by the sentinel node. The sentinel lymph node biopsy with total axillary dissection was performed on 99 patients.