A Phase 1 study was initiated to evaluate the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of margetuximab in patients with HER2-overexpressing carcinomas. Patients and methods Patients with HER2-positive breast or gastric cancer, or other carcinomas that ...
Compared with other types of breast cancer, it is more aggressive, easy to metastasize in the early stage, and has a poor long-term prognosis [9]. Medical therapies based on anti-HER2 therapy have become the cornerstone of treatment for HER2-positive early breast cancer. The use of ...
A Simon minimax two-stage design was used to estimate the sample size, with a one-sided alpha of 5% and power of 80%. The null hypothesis (P0) was set as an ORR of 50%, referring to the ORR of pyrotinib monotherapy in HER2-positive ABC patients in a phase I study31. Since the ...
TUXEDO-1 was designed as a phase 2 study evaluating the ability of trastuzumab deruxtecan to induce objective responses in patients with HER2-positive metastatic breast cancer and with newly diagnosed or progressive brain metastases based on a Simon’s two-stage design40. A response rate of ≤25...
phase 1 study (NCT04235101); a new arm of the I-SPY 2 trial is evaluating the neoadjuvant use of trastuzumab duocarmazine in patients with HER2-low, early-stage breast cancer; and a phase 1 trial (NCT04602117) is examining the ADC in combination with paclitaxel in patients...
breast cancer (TNBC) who are not candidates for anti-PDL1 therapy. In TROPION-Breast03 (NCT05629585), datopotamab deruxtecan will be assessed when given with and without durvalumab (Imfinzi) vs investigator’s choice of therapy in patients with stage I-III TNBC with residual disease after ...
Pavani Chalasani, MD, MPH, discusses the potential clinical significance of the AIPAC-003 trial of eftilagimod alpha in HER2–/HER2-low breast cancer. This is a modal window. The Playback API request failed for an unknown reason Error Code: VIDEO_CLOUD_ERR_UNKNOWN Technical detail...
排除标准 Exclusion Criteria: 1. Known hypersensitivity reaction to one of the compounds or substances used in this protocol. 2. Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible. 3. Patients with known gBRCA1/2 mutation and indicated...
Women aged 18 years or older with biopsy-proven stage IV adenocarcinoma of the breast were eligible if they had at least 1 measurable lesion (by Response Evaluation Criteria in Solid Tumors [RECIST]). The tumor had to be HER2-normal by fluorescence in situ hybridization, and subjects were req...
inoperable or metastatic HR-positive, HER2-negative breast cancer, progressed on or are not eligible for endocrine therapy, have an ECOG performance status of 0 or 1, at least 1 measurable lesion, adequate organ and bone marrow function, and a minimum life expectancy of 12 wee...