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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | tagtociclib (PF-07104091) (CDK2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
PF-07104091 as a Single Agent and in Combination Therapy
Excerpt:
...- Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and...
Trial ID:
Source:
Title:
Phase 1/2a study of PF-07104091 as a Single Agent and in Combination Therapy
Excerpt:
...Part 1:• Participants with HR-positive HER2-negative advanced or metastatic breast cancer (third line plus setting) (histologically or cytologically proven).• Participants with locally recurrent/advanced or metastatic TNBC who have received up to 3 prior lines of chemotherapy in the advanced or metastatic setting.• Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received at least 1 systemic anti-cancer therapy containing a platinum analog.Part 1A only:• Participants with cytological diagnosis of advanced/metastatic SCLC.• Participants with or cytological diagnosis of advanced/metastatic NSCLC.• Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven).Part 2A:• Participants with cytological diagnosis of advanced / metastatic SCLC Part 2B:• Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven)• Availability of adequate archival tumor tissue for submission to the sponsor/central laboratory for confirmatory testing of CCNE1 amplification and additional molecular analyses.Part 2C:• Participants with HR-postive HER2-negative advanced or metastatic breast cancer after prior ET-CDK4/6 inhibitor therapy (histologically or cytologically proven).3. ...
Trial ID:
Less C2 evidence
Source:
Title:
First-in-human phase 1/2a study of a potent and novel CDK2-selective inhibitor PF-07104091 in patients (pts) with advanced solid tumors, enriched for CDK4/6 inhibitor resistant HR+/HER2- breast cancer.
Published date:
05/25/2023
Excerpt:
Treatment with PF-07104091 monotherapy was generally well tolerated and showed antitumor activity in heavily pretreated HR+ HER2- mBC pts who progressed on prior CDK4/6i.
DOI:
10.1200/JCO.2023.41.16_suppl.3010
Trial ID:
