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Association details:
| Biomarker: | HER-2 negative |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | fulvestrant (Selective estrogen receptor degrader) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
HER2-Negative and postmenopausal or premenopausal receiving ovarian ablation or suppression: Preferred Regimens...Second and subsequent line therapy...Selective ER down regulator (fulvestrant).
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:
...Postmenopausal or premenopausal/perimenopausal female patients over 18 years old, and meet one of the following conditions: previous bilateral oophorectomy, or age >= 60 years old; or age = 10% of all tumor cells; (2) HER2 negative is defined as: standard immunohistochemistry (IHC) test results are 0 or 1+; FISH test HER2/CEP17 ratio is less than 2.0 or HER2 gene copy number is less than 4; 3. ...
Trial ID:
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:
More C2 evidence
Source:
Title:
A Study to Compare the Efficacy of Venetoclax Plus Fulvestrant Versus Fulvestrant in Women with Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer who Experienced Disease Recurrence or Progression During or after CDK4/6Inhibitor Therapy
Excerpt:
...- Female and >= 18 years of age- Histological or cytological confirmation of ER+ invasive carcinoma of the breast with documented HER2-negative as per ASCO/CAP criteria status. ...
Trial ID:
Source:
Title:
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
Excerpt:
...- Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer....
Trial ID:
Source:
Title:
Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)
Excerpt:
...- The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines...
Trial ID:
Source:
Title:
Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
Excerpt:
...- HER2 negative...
Trial ID:
Source:
Title:
A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.
Excerpt:
......
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:
...defined as HER2 negative);...
Trial ID:
Source:
Title:
Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Breast Cancer Patients Previously Treated With Palbociclib
Excerpt:
...- Histologically or cytologically confirmed estrogen receptor positive and/or progesterone receptor positive, HER2-negative loco-regional recurrent or metastatic disease...
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:
DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer
Excerpt:
...Stage II or III, HER2 negative, ER positive invasive breast cancer in male or female patients....
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:
Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
Excerpt:
...Patients with cancer confirmed to be HER2-negative....
Trial ID:
Source:
Title:
Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours
Excerpt:
...Part B: Histological or cytological confirmation of ER positive, HER2 negative breast cancer and disease progression or any other solid tumor with a PIK3CA gene mutation....
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:
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:
Source:
Title:
A multicenter, prospective real-world study of chidamide combined with fulvestrant in the treatment of advanced breast cancer
Excerpt:
...Histologically or cytologically confirmed ER and/or PR positive and HER-2 negative, postmenopausal and premenopausal breast cancer patients, but premenopausal patients need to be given ovarian function inhibition (OFS) therapy at the same time (menopausal criteria: Chinese premenopausal female breast cancer patients after adjuvant therapy menopausal judgment criteria and aromatase inhibitors clinical application. ...
Trial ID:
