Active clinical trials for "Breast Neoplasms"

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

The present study aims to optimize psychological treatment for pain after breast cancer by identifying active treatment components. Specifically, a factorial design will be used to evaluate the efficacy and change processes of three psychological treatment components, which have been shown to be efficacious in the treatment of pain after breast cancer.

This early phase I trial studies the possible benefits and/or side effects of topical or oral minoxidil in treating endocrine therapy-induced hair loss (alopecia) in patients with stage I-IV breast cancer. Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early cessation of therapy in women undergoing treatment for breast cancer. Patients on endocrine therapy commonly report hair loss or thinning. Minoxidil is a drug that may promote hair growth and reduce hair loss. Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer.

To evaluate the efficacy and safety of chidamide in combination with abemaciclib and fulvestrant in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy

This study will test any good and bad effects of combining the study drugs pembrolizumab and olaparib, given before the standard surgical procedure, to treat TNBC or HR+ HER2- breast cancers. The study drugs could shrink cancer, but they could also cause side effects. The study researchers want to find out whether the study drugs will shrink the cancer by a certain percentage compared with its current size, which may improve the outcome of surgery.

This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate both RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors and RLY-2608 + fulvestrant combination arm for patients with HR+ HER2- locally advanced or metastatic breast cancer. This study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients with early small (cT1N0) triple negative breast cancer tumors. This study will recruit patients with early HR-negative breast cancer all invasive types (ER < 1%, PR < 1%, HER2 negative) and TILs >=5%, eligible for a short-term treatment with Durvalumab. A total of 200 patients are planned to be enrolled in the study and which will receive 2 administrations of durvalumab 10mg/kg. After study treatment, patients: In whom surgery is the first standard treatment strategy (i.e. after study treatment) no biopsy is required at the end-of-treatment visit. In whom neo adjuvant therapy is the first standard treatment strategy (i.e. after study treatment) a breast ultrasound guided biopsy is mandatory at the EoT visit. If the biopsy-proven residual disease is demonstrated, patients will have the option to receive standard neoadjuvant therapy at the discretion of the treating investigator. Those with a complete response may proceed directly to surgery.

(Neo-)adjuvant chemotherapy for breast cancer has deleterious effects on muscle tissue resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high intensity training vs. low-to moderate intensity training on muscle tissue cellular outcomes and function in breast cancer patients during chemotherapy. The present study aims to compare the effects of high vs. low-to moderate intensity training on its ability to counteract deleterious effects of chemotherapy on skeletal muscle in women diagnosed with breast cancer. Eighty newly diagnosed women with breast cancer planned to start (neo-)adjuvant chemotherapy will be randomized to either a group performing a combination of strength and endurance training with high intensity or a group performing training with low to moderate intensity. Muscle biopsies from m. vastus lateralis for assessment of muscular cellular outcomes will be collected and muscle function and cardiorespiratory fitness will be measured before the first cycle of chemotherapy (or, when not possible, one week after) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% will be willing to take muscle biopsies. The study will give important information about the effects of different training intensities for breast cancer patients during treatment and will contribute with knowledge about how to refine exercise programs that are effective and compatible with multidisciplinary management of breast cancer.

For patients with early breast cancer with negative axillary lymph nodes, sentinel lymph node biopsy (SLNB) can largely avoid complications such as upper limb lymphoedema caused by axillary lymph node dissection (ALND). Locally advanced breast cancer requires neoadjuvant chemotherapy (NAC), based on the breast cancer treatment guidelines. In addition to shrinking the primary breast lesion, NAC can reduce the stage for axillary positive lymph nodes. Therefore, in recent years clinicians have been considering SLNB for patients whose axillary lymph nodes have turned negative after NAC. After verification by the clinical trials, the current NCCN guidelines recommend that patients with T1-3N0-1 undergo SLNB after NAC, however, the false negative rate (FNR) of conventional SLNB after NAC is as high as 14%, which potentially leads to underestimation of the risk for recurrence and metastasis, insufficient adjuvant therapy, eventually affects long-term survival. Thus, how to accurately assess and treat axillary lymph nodes after NAC remains an urgent clinical question to be answered. In recent years, a method using a metal clip to label positive lymph node before NAC has emerged in order to reduce the FNR of SLNB after NAC. Its principle is to trace the metastasized lymph node, so that the lymph node can be accurately found in the surgery, even if the lymph node is not blue-stained at the time. Apparently, this method is more suitable for small number of nodes, and inappropriate for more than two metastasized nodes. The diameter of manocarbon particles (150nm) is between that of lymphatic capillaries (120-500nm) and capillaries (20-50 nm). With the unique macrophage phagocytosis, nanocarbon particles can remain in the lymphatic system for a long time. Using nanocarbon to label positive lymph nodes before NAC, our pilot study explored the regression of axillary lymph nodes after NAC. We found that, except for a small number of drug-resistant patients, the regression of positive lymph nodes after NAC followed a pattern of from the superior to the inferior, and from the medial to the lateral. We also found that, the worse the efficacy of NAC, the fewer black-stained nodes after NAC, suggesting long-term tracing of positive axillary lymph nodes by nanocarbon particles can guide precise treatment of axillary lymph nodes after NAC. These findings are integrated with our previous research project which investigated the spatial distribution of positive axillary lymph nodes with the intercostals brachial nerve (ICBN) as the boundary. It is proposed that low lymph node dissection below ICBN (pALND) may be a safe and efficient method reducing lymphoedema in patients with negative nodes after NAC. Prone position CT scan combined with clinical palpation of axillary lymph nodes can comprehensively evaluate axillary conditions in patients with breast cancer before surgery, and determine node metastasis accurately, and make correct clinical plans.

This study is a multicenter, international, open-label phase II study. Based on inclusion/exclusion criteria, eligible pre and postmenopausal patients with newly diagnosed metastatic luminal hormone receptor-positive and HER2 negative breast cancer, will be prospectively treated with a standard combination of hormone therapy (Letrozole or Anastrozole) and Palbociclib. This combination will continue until progression. Treatment response will be evaluated every three months using clinical and radiological assessments (Revised RECIST guidelines). Patients will undergo serial liquid biopsies (blood tests) for plasma molecular fingerprinting by the Quantum Optics technology. This study will be the first program exploring the adjunction of the Quantum Optics technology on liquid biopsies to define individual 'molecular fingerprinting profiles' to predict the individual therapeutic effects of Palbociclib combined with Aromatase Inhibitors (AI) (plus ovarian function suppression (OFS) for pre/peri-menopausal patients) in luminal hormone receptor-positive and HER2 negative advanced breast cancer. Batteries of algorithmic tests will integrate the variables obtained by Quantum Optics (to evaluate the efficacy or not of the combination of Palbociclib + Aromatase Inhibitors (AI) ). This approach introduces the concept of singularity to break from the classic idea of "one size fits all".