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Uses of chidamide and exemestane in preparation of concomitant drugs for treatment of breast cancer, and concomitant drug

A technology of chidamide and exemestane, which is applied in the field of chemical pharmaceuticals and can solve problems such as not obtaining clear curative effects

Active Publication Date: 2019-01-01
SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A total of 16 patients with solid tumors were enrolled in the phase I clinical trial of Chidamide, including non-small cell lung cancer, breast cancer, colon cancer, rectal cancer, gastric cancer, prostate cancer, etc., except for 1 patient with adenoid cystic carcinoma of the submandibular gland Except for the partial remission, the rest of the solid tumors have not achieved definite curative effect. The Phase I clinical results show that Chidamide monotherapy is ineffective for breast cancer. Therefore, in the Phase II clinical trial of Chidamide, breast cancer patients were not enrolled. cancer patient

Method used

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  • Uses of chidamide and exemestane in preparation of concomitant drugs for treatment of breast cancer, and concomitant drug
  • Uses of chidamide and exemestane in preparation of concomitant drugs for treatment of breast cancer, and concomitant drug
  • Uses of chidamide and exemestane in preparation of concomitant drugs for treatment of breast cancer, and concomitant drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: Clinical trial of combined use of Chidamide Tablets and Exemestane Tablets

[0036] A total of 20 patients were selected for this clinical trial, and the selected patients must meet all the following criteria:

[0037] 1) 18-75 years old, postmenopausal women* patients;

[0038] 2) Hormone receptor positive [estrogen receptor (ER) positive, progesterone receptor (PgR) negative or positive] breast cancer patients confirmed by histology or cytology;

[0039] 3) The disease progresses or recurs after at least one endocrine drug therapy (whether salvage therapy or adjuvant therapy);

[0040] 4) The total number of regimens of salvage therapy or adjuvant therapy before enrollment is ≤4, and the number of salvage chemotherapy regimens is ≤1;

[0041] 5) Patients with inoperable stage III or stage IV breast cancer with at least one measurable lesion or no measurable lesion and simple bone metastasis before enrollment;

[0042] 6) Time interval from the last treat...

Embodiment 2

[0061] Example 2: Clinical Trial Efficacy Results of Chidamide Tablets and Exemestane Tablets Combined Medication

[0062] The main efficacy indicators are as follows:

[0063] √Objective response rate: the percentage of patients with complete remission (CR) and partial remission (PR) in the total number of analysis sets and their 95% CI;

[0064] √Progression-free survival (PFS): The distribution of PFS was estimated by the kaplan-Meier method, and the survival curve was drawn.

[0065] Efficacy results: The clinical results of this clinical trial of chidamide combined with exemestane in the treatment of HR-positive advanced breast cancer are as follows. This trial enrolled 20 patients with HR-positive HER-negative breast cancer, 3 patients achieved partial response, and 12 patients achieved partial response. The patient achieved stable disease. Three patients discontinued the drug due to adverse reactions, and the adverse reactions above grade 3 included neutropenia (35%),...

Embodiment 3

[0068] Embodiment 3: Combined use pharmaceutical composition

[0069] The combined pharmaceutical composition of this embodiment comprises 1 exemestane tablet (25 mg) and 6 chidamide tablets (30 mg).

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Abstract

The present invention relates to uses of chidamide and exemestane in preparation of concomitant drugs for treatment of breast cancer, a pharmaceutical composition or concomitant drug containing chidamide and exemestane, and a method for treating breast cancer by combining chidamide and exemestane.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and specifically relates to the use of chidamide and exemestane in preparing a combined drug for treating breast cancer and the combined drug. Background technique [0002] Exemestane, chemical name 1,4-diene-3,17-dione-6-methyleneandrostane or 6-methyleneandrostane-1,4-diene-3,17-di Ketone, white or off-white crystalline powder; odorless. Soluble in chloroform, soluble in ethyl acetate, acetone, methanol or ethanol, almost insoluble in water. It is clinically applicable to postmenopausal patients with advanced breast cancer whose disease has progressed after tamoxifen treatment. [0003] Breast cancer is the female malignancy with the highest incidence in the world and in my country. The molecular classification of breast cancer is related to prognosis and treatment response, and plays a dominant role in treatment decision-making. At the St Gallen International Breast Cancer Conference in Mar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5685A61K31/4406A61P35/00
CPCA61K31/4406A61K31/5685A61K2300/00
Inventor 鲁先平宁志强曹海湘
Owner SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD