Active clinical trials for "Breast Neoplasms"

This is a multicenter, open-label clinical study to evaluate the safety and antitumor activity of FCN-437c in combination with Fulvestrant for the treatment of post-menopausal female patients with ER+ and HER2- advanced breast cancer, FCN-437c in combination with Letrozole + Goserelin for the treatment of pre-menopausal female patients with ER+ and HER2- advanced breast cancer, and to evaluate the PK characteristics of the FCN-437c combination therapies. This study is consist of two cohorts, Cohort 1: FCN-437c in combination with Fulvestrant (1st or 2nd line treatment for postmenopausal ER+, HER2-advanced breast cancer); Cohort 2: FCN-437c in combination with Letrozole + Goserelin (1st line treatment for premenopausal ER+, HER2- advanced breast cancer). Thirty patients will be enrolled in each cohort, for a total of 60 patients. Tumor Assessment: Tumor evaluation will be performed every 8 weeks (±7 days) according to RECIST version 1.1 until disease progression, withdrawal of informed consent, or death; for patients who discontinue the drug due to toxicity, imaging evaluation is required until disease progression. End of Treatment and End of Study: End of Study (EOS) is defined as 2 years after the last patient's first dose or the end of treatment (whichever is earlier). At the end of the study, the investigator will decide whether the patients whose disease has not progressed shall continue taking FCN-437c and other combination agents or not based on clinical benefit. Cohort 1: Post-menopausal patients diagnosed with ER+, HER2- advanced breast cancer, who have not received prior systemic therapy for advanced breast cancer, or who have disease progression determined by imaging assessment during their 1st line endocrine therapy; Cohort 2: Pre-menopausal patients diagnosed with ER+, HER2- advanced breast cancer, who have not received prior systemic therapy for advanced breast cancer;

Investigating the potential role of a novel quadrate combination therapy Mifepristone(Antiprogestrone), Tamoxifen, Retinoic acid and Cannabidiol ( selective cyp 26 inhibitor) for treating early breast cancer. Breast cancer is the main cause of mortality among women. The disease presents high recurrence mainly due to incomplete efficacy of primary treatment in killing all cancer cells. Therapy resistance remains a major problem in estrogen receptor-α (ERα)-positive breast cancer. Half of estrogen receptor-positive breast cancers contain a subpopulation of cytokeratin 5 (CK5)-expressing cells that are therapy resistant and exhibit increased cancer stem cell (CSC) properties. Here, we propose a testable hypothesis that treatment of breast cancer with tamoxifen or retinoic acid or a combination of the two, may result in induction or conversion of some ER-positive breast cancer cells to ER-negative cancer cells expressing the basal cytokeratin-5 (CK5) via stimulation of progesterone receptors effect, and production . Therefore, we raised an issue with the answer " Why Antiprogestrone such Mifepristone and cyp 26 inhibitors must be combined with Tamoxifen or its combination with retinoic acid in the era of oncology for treating early breast cancer" .In fact, limited evidence has indicated that induction of CK5+ cells in ERα+ breast cancer is a unique effect of progestin (Prg) but many studies have demonstrated that progesterone (P4) increases CK5+ breast cancer cells. In case-cohort study of 405 incident breast cancer cases, elevated circulating progesterone levels were associated with a 16% increase in the risk of breast cancer. A study demonstrated that tamoxifen induced progesterone receptors (PGR) in short term treatment. Another study showed that High progesterone receptor expression correlates to the effect of adjuvant tamoxifen in premenopausal breast cancer patients. These CK5-positive cells are therapy resistant and have increased tumor-initiating potential. Also, previous work has shown that retinoic acid, a chemical that results from the body's natural breakdown of vitamin A, should act against these CK5+ cells, but clinical trials of retinoids against breast cancer have been largely unsuccessful .Therefore we suggest that combination of retinoiac acid and tamoxifen was unsucssecful in treating breast cancer owing its ability to induce progesterone receptors and production leading to increasing numbers of CK5-positive cells which are therapy resistant . Although retinoid fenretinide reduced the accumulation of CK5+ cells during estrogen depletion. A study investigated the effects of all-trans-RA (atRA) on progesterone production in immature rat GCs cultured without gonadotropin. demonstrated that atRA enhanced progesterone production by upregulating the levels of steroidogenic acute regulatory protein (StAR) and cytochrome P450scc (Cyp11a1). Here, we suggest that tamoxifen or its combination with retinoic acid must be combined with anti-progesterone (Mifepristone) to achieve treatment with significant effect against early breast cancer. Moreover, Numerous studies have shown that CYP2D6 variant carriers (around 50% CYP2D6 variant carriers in Chinese population) will not benefit a lot from tamoxifen, and combined use of CYP2D6 inhibitors will further affect the efficacy of tamoxifen. In addition, All-trans-retinoic acid acts as an inducer of CYP26A1 expression. Which is the second expected cause of unsuccessful trial of Tamoxifen and retinoic acid in breast cancer treatment. Furthermore, The CYP26 inhibitor also induced expression of atRA-responsive genes. All-trans retinoic acid (ATRA) significantly inhibited aromatase activity in a concentration-dependent manner in microsomes isolated from JEG-3 human placental carcinoma cells. One study found that high retinol was significantly. associated with reduced breast cancer risk. Another found a significant trend of reduced retinol levels with more advanced disease stage. A study showed that intake of vitamin A and retinol could reduce breast cancer risk. Therefore we will take the benefit of cyp 26 inhibitor in this trial by combining Cannabidiol, a major phytocannabinoid, as a potent atypical inhibitor for CYP2D6.

This will be a single arm, open label pilot to test the combination of dapagliflozin, a commercially available SGLT-2 inhibitor, in combination with alpelisib + fulvestrant in patients with HR+/HER2- mBC. The objective of this study is to determine if the addition of dapagliflozin to the combination of alpelisib and fulvestrant leads to significant reduction in all-grade hyperglycemia.

The hypothesis of this study is to discover if the oral Etoposide plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC. It is a single-arm, multicenter phase II clinical study of oral etoposide combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer

HR+/HER2+（Human epidermal growth factor receptor 2 positive and hormone receptor positive）metastatic breast cancer is a special subtype of HER2+breast cancer. Conventional guidelines recommend chemotherapy combined with trastuzumab targeted therapy for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Pyrotinib is a new class I small molecule Tyrosine kinase inhibitors（TKI） drug with high efficacy and low toxicity after the progress of trastuzumab therapy. Fulvestrant is the most preferred single-drug therapy for HR + metastatic breast cancer recommended unanimously by the guidelines, and fulvestrant and small molecule TKI have synergistic effects. Therefore, we envisage that fulvestrant combined with Pyrotinib in the treatment of HR+/HER2+ metastatic breast cancer in clinical practice has the advantages of improving efficacy and survival. To this end, we intend to conduct a prospective, multi-center, phase II clinical trial to evaluate the efficacy and safety of erlotinib in combination with fulvestrant in patients with human epidermal growth factor receptor 2 (HER2) positive，hormone receptor-positive metastatic breast cancer.

This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.

The purpose of this study is to identify the highest tolerable dose of pyrotinib in combination with vinorelbine and to assess the safety and efficacy of the combination in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of pyrotinib and vinorelbine in patients with advanced solid tumors. In the second part of the study, we will compare the safety and efficacy of Pyrotinib + vinorelbine vs. Treatment of Physician's Choice in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy.Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination.

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.

This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.

Brain metastasis accounted for 10-15% of all breast cancer patients and even higher in patients with triple negative and HER2 overexpressed subtype. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, many studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. Also, several studies had demonstrated that 5-10 lesions had similar overall survival by using whole brain radiotherapy or stereotactic radiotherapy. Fractionated stereotactic radiotherapy(FSRT) is increasingly administered in the brain metastatic patients and retrospective studies had shown that FSRT had better local control and lower brain radiation necrosis than single fraction stereotactic radiation. Therefore, In this study, we explore to treat 1-10 brain metastasis lesion in breast cancer patients with FSRT.