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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | fulvestrant (Selective estrogen receptor degrader) |
| Drug Class: | CDK4 inhibitor + CDK6 inhibitor |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Multicenter, Randomized, Controlled, Double-Blind Phase III Study of BEBT-209 in Combination with Fulvestrant Versus Placebo in Combination with Fulvestrant in HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy
Excerpt:
......
Trial ID:
Source:
Title:
Phase Ib/II clinical trial of BEBT-908 combined with BEBT-209 in patients with advanced recurrent or metastatic HR+/HER2- breast cancer
Excerpt:
...Patients with advanced recurrent or metastatic breast cancer diagnosed by histology, immunohistochemical detection of HR positive staining cells >= 10% and HER2 negative (receive the latest metastatic tissue sample or previous primary tumor tissue sample test results), menopausal state or receiving LHRH agonist treatment, there is evidence of focal recurrence or metastasis, not suitable for surgical resection or radiation therapy for the purpose of cure; those who meet any of the following can be considered to have reached the menopausal state: (1) Premenopausal/perimenopausal female patients agree to use concomitant luteinizing hormone-releasing hormone (LHRH agonist), and start receiving LHRH agonist treatment at least 28±2 days before the first dose of study dosing can be considered to meet the inclusion criteria3 (Those who have used LHRH agonist for >=21 days but = 60 years; aged = 12 months, follicle-stimulating hormone (FSH) and estradiol (E2) levels in the postmenopausal range without chemotherapy, tamoxifen, toremifene, or ovarian castration within the past year (judged based on the reference range of each research center); (3) For patients aged = 1500/mm^3 (1.5 x 10^9/L); (2) Platelets >= 100000/mm^3 (100 x 10^9/L); (3) Hemoglobin >= 9g/dL (90g/L); (4) Both ALT or AST are l bilirubin (TBIL) =60mL/min (according to Cockcroft and Gault formula); Note: No blood components, hematopoietic-stimulating factors (including granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, erythropoietin, and thrombopoietin, etc.) are allowed within the first 14 days of screening laboratory tests. ...
Trial ID:
More C2 evidence
Source:
Title:
A Multicenter, Randomized, Controlled, Double-Blind Phase III Study of BEBT-209 in Combination with Fulvestrant Versus Placebo in Combination with Fulvestrant in HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy
Excerpt:
...Histologically confirmed HR-positive, HER2-negative breast cancer patients (receiving the test results of tissue samples from recurrent/metastatic lesions or tissue samples from previous primary lesions, based on the latest test results): a) ER-positive and/or PR-positive defined as: ER/PR-positive staining of tumor cells in ≥ 10% of all tumor cells; b) HER2-negative defined as: standard immunohistochemistry (IHC) test results of 0 or 1+; FISH HER2/CEP17 ratio less than 2.0 or HER2 gene copy number less than 4; 3. ...
Trial ID:
Source:
Title:
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Excerpt:
...Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)`Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501`Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 in participants with solid tumors`Part 1: RDFE of BG-68501 and fulvestrant in participants with hormone-receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer`Part 2: Objective Response Rate...
Trial ID:
Source:
Title:
Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients
Excerpt:
...Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory....
Trial ID:
Source:
Title:
I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers
Excerpt:
...Patient has pathologically confirmed hormone receptors (HR)-positive (ER+ and/or PgR+) and HER2-negative advanced BC by local laboratory on the last tissue examined....
Trial ID:
Source:
Title:
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
Excerpt:
...- Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection,...
Trial ID:
Source:
Title:
VS-6766+Abema+Fulv in Met HR+/HER- BC
Excerpt:
...- Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer....
Trial ID:
Source:
Title:
Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.
Excerpt:
...- Participants with HR-positive HER2-negative locally advanced or metastatic breast cancer....
Trial ID:
Source:
Title:
Advanced Breast Cancer Study of CDK4/6 Inhibitor Combined With Endocrine Therapy Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
Excerpt:
...2) For breast cancer patients diagnosed as HR-positive and HER2-negative by pathological examination, the expression levels of ER, PR, and HER2 were reported by immunohistochemistry in the primary or metastatic lesions....
Trial ID:
Source:
Title:
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
Excerpt:
...- Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer...
Trial ID:
Source:
Title:
Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients
Excerpt:
...Diagnosis of hormone receptor positive (HR+), HER2 negative breast cancer....
Trial ID:
Less C2 evidence
Source:
Title:
CDK4/6 inhibitors, PI3K/mTOR inhibitors, and HDAC inhibitors as second-line treatments for hormone receptor-positive, HER2-negative advanced breast cancer: a network meta-analysis
Published date:
08/29/2023
Excerpt:
Compared with placebo plus fulvestrant, PFS was significantly improved by CDK4/6 inhibitor plus fulvestrant, mTOR inhibitor plus fulvestrant, mTOR inhibitor plus exemestane, and PI3K inhibitor plus fulvestrant, but not HDAC inhibitor plus exemestane….mTOR inhibitor and CDK4/6 inhibitor-based regimens demonstrated superior clinical efficacy and comparable safety profiles as second-line treatment in patients with HR-positive, HER2-negative advanced breast cancer.
DOI:
10.1186/s12885-023-11290-7
