Single arm phase ii trial

Results: Between July 1 and August 16 , 15 patients were accrued in the first stage. Response was assessable in all patients, and 13 had squamous histology. Median follow-up time was Patients without liver metastasis also had longer PFS than those who had live metastasis 5.

The common side effects of apatinib were hypertension, hand-foot syndrome, proteinuria, and diarrhea. The incidence of grade hypertension, hand-foot syndrome, proteinuria, and diarrhea was All of the patients received dose reduction because of adverse effect. It is expected that about people will take part in this research study. MedlinePlus related topics: Breast Cancer Hormones.

Drug Information available for: Trastuzumab Pertuzumab. FDA Resources. Arms and Interventions. Outcome Measures. Other Outcome Measures: Patient-reported hormonal therapy adherence [ Time Frame: 5 years ] assessed by Voils questionnaire. Responses to survey items will be summarized using means or proportions depending on the nature of the questions. Responses to survey items will be summarized by means or proportions depending on the nature of the items.

The 6 questions in the WPAI questionnaire were generated from three main sources Responses to survey items will be summarized by means or proportions depending on the nature of the items. There is increasing recognition of the profound importance of the financial strain on patients created by cancer diagnosis and therapies.

The COST Comprehensive Score for financial Toxicity measure has been developed and validated as a mechanism to assess financial stress related to cancer diagnosis and treatment Responses to survey items will be summarized by means or proportions. Eligibility Criteria. If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative.

Any axillary lymph node with tumor clusters between 0. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the overall principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.

For unifocal disease, all invasive disease must have been tested for ER and PR for multifocal disease, see below. ER- and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol. A pathology report documenting testing by NeoGenomics should be provided at time of patient registration. Bilateral breast cancers that individually meet eligibility criteria are allowed. Patients with a history of ipsilateral DCIS are eligible as long as the patient has not received prior hormonal therapy.

Patients with a history of contralateral DCIS are not eligible. All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy lumpectomy , with either a sentinel node biopsy or axillary dissection -- All margins should be clear of invasive cancer or DCIS i.

May have received up to 8 weeks of hormonal therapy as adjuvant treatment for this cancer. Patients should otherwise not have received prior hormonal therapy. Prior oophorectomy including for cancer therapy is allowed. Patients undergoing breast conservation therapy i.

After confirming eligibility and obtaining a signed informed consent form, each patient will be registered and will receive treatment. Patient recruitment began in August It is expected to continue for the next two years. During the trial, samples of tumor tissues will be collected, including biopsy samples and surgical tumor tissue samples.

Blood samples and fecal samples will be collected before every cycle of neoadjuvant therapy and before surgery. The tumor tissues and blood samples will be used for whole genome sequencing, whole transcriptome sequencing, and single-cell sequencing. The fecal samples will be used for 16S rDNA sequencing and nontargeted metabolomics. Adjustment of the dosage regimens in case of adverse events AEs occurring during the trial shall be based on the dose-adjustment regulations specified on the drug medication guides or relevant clinical decisions taken by the researchers.

The primary endpoint measure is the MPR rate. The exploratory endpoint measure is the establishment of an artificial intelligence prediction system for neoadjuvant therapy effect prediction and exploration of drug resistance mechanisms. This system will be based on the multiomics data, including radiomics, metabolism, genetic, and pathological characteristics. A detailed description is provided in Figure 3. Detailed description of the artificial intelligence prediction system used to assess neoadjuvant-based therapy efficacy.

Pre-treatment evaluations of the patients are compulsory and include chest and abdomen-enhanced computed tomography CT scans, brain magnetic resonance imaging scans, bone scans or positron emission tomography scans, and electrocardiography. Patients will undergo a tumor evaluation using a chest-enhanced CT scan before the third cycle of neoadjuvant therapy and prior to surgery. AEs will be recorded using version 5. Descriptive statistics will be used to summarize the demographic data and baseline characteristics of the patients, and a t -test, a chi-square test, or a rank sum test will be used to assess group equilibria.

For the treatment sensitivity analysis of the biomarkers, the Cox univariate and multivariate analyses will be used to analyze the correlation between biomarker expression, clinical efficacy, and prognosis.

Artificial intelligence algorithms will be used to establish a prediction system for the neoadjuvant therapy outcome based on the multiomics data. Moreover, transfer learning algorithm will be used, which refers to the method of transferring the pre-trained CNN model to other datasets and relearning the characteristics of the target dataset. Data augmentation will be adopted to increase the size of the training dataset and expand the existing samples by iterations of random translational shift, rotation, and horizontal and vertical flips.

The performance of the prediction system will be evaluated using the receiver operating characteristic curve, the corresponding AUC, the diagnostic accuracy, sensitivity, specificity, the positive predictive value, and the negative predictive value. All statistical analyses will be performed with R software 4. The sample size was calculated using the Simon two-stage method. MPR rates of Therefore, an MPR rate of The sample size for the first stage was If more than three cases reach the MPR, the second stage will begin, in which 27 cases will be included.

The results of this trial will be considered positive if more than 13 cases out of 40 effective cases reach MPR. Effective cases are defined as patients who received at least once cycle of neoadjuvant therapy and completed the first tumor assessment.

All patients enrolled in the trial have signed or will sign informed consent forms prior to registration according to the Declaration of Helsinki as revised in This protocol has been registered at ClinicalTrials. As of August , three subjects have been enrolled and have signed the informed consent forms.

Although many ongoing trials focus on the identification of new biomarkers, such as PD-L1 and TMB, usable as potential surrogates for the prediction of clinical outcomes, current strategies and biomarkers for predicting ICI efficacy are still limited.