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This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4/6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4/6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called autophagy to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the bodys immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseasesincluding cancers. One way the immune system controls the activity of T cells is through the PD-1/PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1/PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1/PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.

The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:

1. what is the maximum tolerated dose and recommended dose for phase 2?

2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?

This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups are
as follows:

Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI, Novartis Pharmaceuticals
Corporation).

Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY, Novartis Pharmaceuticals
Corporation).

This is a Phase III, randomized, open-label, 3-arm, multicenter, international study
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in
participants with stage I to III TNBC with residual invasive disease in the breast and/or
axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

This phase II trial studies the effect of hormonal therapy given after (adjuvant) combination pertuzumab/trastuzumab in treating patients with hormone receptor positive, HER2 positive breast cancer. The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. Estrogen can cause the growth of breast cancer cells. Hormonal therapy, such as letrozole, anastrozole, exemestane, and tamoxifen, block the use of estrogen by the tumor cells. Giving hormonal therapy after pertuzumab and trastuzumab may kill any remaining tumor cells in patients with breast cancer.

This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the
RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib,
and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the
various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib blocks HER2, which may help keep cancer cells from growing and may kill them. Giving T-DM1 in combination with tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

This phase III trial compares the effect of radiation therapy combined with hormonal therapy versus hormonal therapy alone in treating patients with low risk, early stage breast cancer with Oncotype Dx Recurrence =< 18. Oncotype DX is a laboratory test which results in a score that is used to help predict whether breast cancer will spread to other parts of the body or come back. Radiation therapy uses high doses of radiation to kill cancer cells and shrink tumors but may result in some side effects. Hormones called estrogen and progesterone may contribute to the growth of breast tumor cells. Hormone therapy, also called endocrine therapy, may stop the growth of tumor cells by blocking or removing these hormones. This clinical trial may help researchers understand if patients with low-risk, early stage breast cancer who have Oncotype recurrence score of =< 18 can safely omit radiation therapy and only be treated with hormonal therapy without losing any radiation treatment benefit.