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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | sapanisertib (CB-228) (mTORC1 inhibitor, mTORC2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
Excerpt:
...Histological confirmation and documentation of estrogen receptor (ER)-positive status (≥1% positive stained cells)....
Trial ID:
Source:
Title:
TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer
Excerpt:
...Newly diagnosed ER-positive, HER2-negative breast cancer....
Trial ID:
More C2 evidence
Source:
Title:
Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer
Excerpt:
...Post-menopausal women ≥18 years of age with clinical stage I-IV, ER positive / HER2 negative, breast cancer that will be managed by surgical resection....
Trial ID:
Less C2 evidence
Source:
Title:
Sapanisertib Plus Fulvestrant in Post-Menopausal Women with Estrogen Receptor-Positive/HER2-Negative Advanced Breast Cancer After Progression on Aromatase Inhibitor
Published date:
01/03/2022
Excerpt:
Median progression-free survival (PFS; primary endpoint) was 3.5 months in the single-agent fulvestrant arm, compared with 7.2 months for fulvestrant plus sapanisertib QD (hazard ratio, 0.77; 95% confidence interval, 0.47-1.26) and 5.6 months for fulvestrant plus sapanisertib QW (0.88; 0.53-1.45)....Fulvestrant plus sapanisertib QD/QW resulted in numerically longer PFS in patients with ER+/HER2- advanced or metastatic breast cancer, compared with single-agent fulvestrant.
Secondary therapy:
fulvestrant
DOI:
10.1158/1078-0432.CCR-21-2652
Trial ID:
Source:
Title:
Safety and efficacy study of oral metronomic vinorelbine combined with trastuzumab (mNH) in HER2-positive metastatic breast cancer: a phase II trial
Published date:
04/15/2021
Excerpt:
Tamoxifen and TAK-228 was safe and well tolerated neoadjuvant treatment for ER+ breast cancer, preliminary evidence of activity with significant reduction in both Ki-67 and tumor size…
DOI:
10.1007/s10549-021-06216-5
Trial ID:
Source:
Title:
Open-label, randomized, phase 2 study of sapanisertib (TAK-228/MLN0128) in combination with fulvestrant in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor-2-negative (HER2-) advanced or metastatic breast cancer (MBC) that previously progressed during or after aromatase inhibitor therapy (NCT02756364)
Published date:
11/17/2020
Excerpt:
Daily or weekly treatment with S + F demonstrated modest clinical benefit in ER+/HER2- advanced or MBC pts who progressed during/after AI compared with single-agent F...
Secondary therapy:
fulvestrant
Trial ID:
