HER-2 negative + PGR positive

Our study suggests differential tamoxifen benefit by menopausal status. Improved long-term endocrine therapy prediction in premenopausal patients is needed and could involve molecular markers because standard tumor characteristics cannot predict benefit beyond 10 years.

P2, N=60, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Dec 2024 --> Jun 2025

P2, N=200, Recruiting, Oana Danciu | Trial completion date: Dec 2027 --> Aug 2029 | Trial primary completion date: Dec 2024 --> Aug 2028

P1, N=24, Active, not recruiting, National Cancer Institute (NCI) | Phase classification: P1/2 --> P1 | Trial completion date: Mar 2025 --> Jul 2025

P1, N=44, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Apr 2017 --> Sep 2024

Surgery was not possible due to comorbidities, so fulvestrant(500 mg/month)+denosumab(120 mg/month)was started. Furthermore, as the tumor markers were elevated, abemaciclib(300 mg/day)was added, which resulted in a decrease in the tumor markers...During the course of treatment, the tumor markers rose again, so the dose was increased to 250 mg/day, which resulted in a decrease in the tumor markers and good tolerability. At present, 36 months after the start of treatment, long SD has continued, no adverse events of grade 3 or higher have been observed, and the drug has been well tolerated.

We judged that both patients were at intermediate risk of recurrence and administered S-1 in addition to endocrine therapy. Even in cases without axillary lymph node metastasis, this combination of S-1 with endocrine therapy was considered to be a useful treatment option if the criteria of the POTENT trial were met.

IVIM-related metrics exhibited relationships with breast cancer molecular prognosis factors and subtypes.

P3, N=1684, Active, not recruiting, West German Study Group | Recruiting --> Active, not recruiting

P2, N=60, Recruiting, The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

Together, the results suggest that mRNA expression of ESR1, ESR2, and PGR might differ depending on menopausal status in breast tumors with certain receptor status. More importantly, the change in the expression of ESR1 and ESR2 following menopause is in the opposite directions in breast cancer patients showing the need to identify particular molecular mechanisms regulating the expression of ER isoforms post-menopause in different directions in breast cancer patients, considering the high clinical importance of these receptors in terms of the prognosis of patients with breast cancer.

P3, N=1979, Recruiting, Henan Cancer Hospital | Trial primary completion date: Sep 2024 --> Sep 2025

Our study shows that among high genomic risk, node-negative, premenopausal patients, the survival rates are numerically similar between Caucasians and African Americans (AAs) when chemotherapy was administered. However, when chemotherapy was omitted, there were numerical differences in the survival rates within the high-risk RS population. This trend was not observed with the MP cohort.

Only the established Johns Hopkins University calculator demonstrated good performance in correctly stratifying our patients. This highlights the need for further refinement and validation in predictive models across diverse patient populations to optimize medical decisions.

Pts are randomized post-BCS to Arm 1 with breast RT using standard methods (moderate or ultra hypo- or conventional-fractionated whole breast RT with/without boost, or APBI) with ≥5 yrs of ET (tamoxifen or AI) or Arm 2 with ≥5 yrs of ET (tamoxifen or AI) alone...As of July 3, 2024, 1,033 pts have been screened and 927 randomly assigned. NCT #: NCT04852887.

Subsequently, he received androgen deprivation therapy (ADT) for 6 months with triptorelin and bicalutamide...The pathological stage was pT1c pN1mi.The Oncotype DX study had a Recurrence Score (RS) of 22 points, leading to a recommendation for adjuvant chemotherapy with Docetaxel-Cyclophosphamide for 4 cycles, followed by tamoxifen...Early detection through screening and appropriate medical follow-up improves the prognosis in patients carrying PV in BRCA2. Therefore, risk control monitoring and adequate genetic counseling are necessary.

P2, N=16, Recruiting, Wake Forest University Health Sciences | Trial completion date: Jan 2025 --> Jan 2027 | Trial primary completion date: Oct 2024 --> Mar 2025

P2, N=200, Recruiting, Oana Danciu | Active, not recruiting --> Recruiting

Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic, or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy. No participants are currently ineligible. There have been no Grade 4 or higher adverse events reported among the 26 participants assessed for adverse events.

P2, N=376, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed

This patient had a history of right ER/PR positive HER2 negative stage 1 breast cancer s/p lumpectomy with sentinel lymph node biopsy and radiation plus tamoxifen x6 months in 2017...No right-sided sentinel node was identified. The right breast lesions and the left axillary lymph node metastases are all morphologically similar and showed strong ER expression, the results of which are compatible with spreading to the contralateral axilla.

In the next phase, we aim to combine transcriptomic information with radiographic features to develop image-based breast cancer risk prediction models. This can aid in individualized breast cancer risk assessment and potentially guide personalized screening, prevention recommendations, and treatment decisions.

P1, N=45, Recruiting, Mayo Clinic | N=33 --> 45

P2, N=620, Recruiting, Fudan University | N=140 --> 620

P1, N=30, Suspended, University of Michigan Rogel Cancer Center | Recruiting --> Suspended

P2, N=200, Active, not recruiting, Oana Danciu | Recruiting --> Active, not recruiting

Treatment typically follows protocols for female breast cancer, including surgery, chemotherapy, and hormone therapy, with tamoxifen being commonly used. Further research is needed to better understand its pathogenesis and to develop more effective, tailored treatments.

P1/2, N=170, Active, not recruiting, Cyteir Therapeutics, Inc. | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Jul 2024 --> Dec 2024

P2, N=43, Recruiting, City of Hope Medical Center | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025

P1, N=44, Active, not recruiting, National Cancer Institute (NCI) | Completed --> Active, not recruiting | Trial completion date: Apr 2017 --> Aug 2025

Genetic testing of the excised tumor revealed a MUTYH gene mutation and a BARD1 (BRCA1-associated RING domain 1) gene mutation of unknown significance. Histopathological analysis confirmed a Grade 2, ER/PR-positive, KI 67-positive, and HER2-negative tumor.

Although tamoxifen therapy is an essential treatment, the long-term benefit for patients with luminal A and B subtype is not well understood. Secondary analysis of 952 ER-positive/HER2-negative patients with luminal A or B molecular subtype from the Stockholm Tamoxifen 2, 3 and 5 trials randomized to receive tamoxifen therapy (tamoxifen alone or with goserelin) or control. Our findings suggest a long-term benefit from tamoxifen for most patients with less aggressive tumor characteristics irrespective of molecular subtype, but the benefit differed by menopausal status. Luminal B patients with PR-positive, lymph node-negative or low genomic risk tumors had a higher risk as compared to patients with luminal A tumors.