View clinical trials related to Breast Neoplasms.
Filter by:Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.
Background: Several clinical trials are underway to investigate if variable forms of vitamin D (D2 vs. D3) prescribed at different doses (10,000-50,000 IUs/week) can improve the side-effects associated with treatment for estrogen receptor positive (ER+) breast cancer, specifically aromatase inhibitors (AIs.) Presumably for generalizability and potential safety purposes, these trials predominantly exclude women with metastatic breast cancer (MBC); a rapidly expanding sector of the cancer survivor population who experience significant treatment-related side-effects. Evaluation of the safety of vitamin D3 supplementation is crucial since supplementation can lead to high calcium and importantly, in lab studies have shown that vitamin D3 affects a gene that increases estrogen production. To assure that vitamin D3 does not affect the clinical effects of anti-estrogen therapies, the effect of vitamin D3 supplements on estrogen production requires an evaluation that further explores and defines its potential role in symptom management for this population. Objectives: This pilot study will evaluate the feasibility of vitamin D3 supplementation in women with MBC, providing much needed data on the preliminary safety and efficacy of this treatment in this patient population. This study will determine: 1) if weekly supplementation of high dose vitamin D3 increases serum vitamin D levels without adverse effects related to such therapy (primary aim); 2) the effects of vitamin D3 supplementation on symptom management (secondary aim); and 3) if vitamin D3 supplementation is associated with improved inflammation (exploratory aim.) Methods: This is an 8 week "proof of concept" study to monitor laboratory parameters and to assess potential effects on short-term outcomes. Adult, female patients (>=18 years) with ER+ MBC (Stage IV) of any race/ethnicity and a history of vitamin D < 30 mg/dl will be recruited from within and around LUMC. Following current clinical practice guidelines, eligible participants will receive 50,000 IUs of vitamin D3 weekly for 8 weeks. Laboratory values, muscle function and inflammation will be examined pre- and post-supplementation, while symptoms will be assessed at baseline, 4 and 8 weeks post-supplementation. We will assess if increases in vitamin D are associated with clinically significant improvements in symptoms and QOL, and decreased inflammation.
This is an open-label, multicenter, 2x2 factorial design, randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC)-chemotherapy, followed by 3 cycles of Docetaxel(Doc)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide(FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DocGemzar)-chemotherapy, and to compare the disease free survival after randomisation in patients treated with 2 years of Zoledronate versus 5 years of Zoledronate in patients with early primary breast cancer. Patients will be required to have histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: 'pT≥2 or histopathological grade 3, or age ≤ 35 or negative hormone receptor', but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study. After surgery, leading to R0 resection of the invasive and intraductal components of the primary tumor, patients will be randomized to one of the following treatments: First randomization AA: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (Doc), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (Gemzar), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22 AB: 3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (Doc), administered on day 1, repeated on day 22 Second randomization B BA: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years, subsequently followed by zoledronic acid 4 mg i.v., every 6 months for the duration of additional three years BB: Zoledronic acid 4 mg i.v., every 3 months for the duration of two years During the zoledronic acid treatment period, patients will receive 500 mg Calcium p.o. qid and 400 i.E. Vitamin D p.o. qid. Patients with positive hormone receptor status (≥ 10 % positively stained cells for estrogen and/or progesterone) of the primary tumor will receive Tamoxifen treatment 20 mg p.o. per day for 2 years, after the end of chemotherapy. Subsequent to chemotherapy, postmenopausal patients with positive hormone receptor status will be treated with Anastrozole (Arimidex®) 1 mg p.o. for additional 3 years, premenopausal patients will continue Tamoxifen treatment for additional 3 years. In addition to tamoxifen, all patients with positive hormone receptor status of the primary tumor and under the age of 40 or restart of menstrual bleeding within 6 months after the completion of cytostatic treatment or with premenopausal hormone levels as defined below will receive Goserelin (Zoladex®) 3.6 mg subcutaneously every 4 weeks over a period of 2 years following chemotherapy. Premenopausal endocrine status will be assumed, if the following serum levels are met: Luteinizing hormone (LH) < 20 mIE/ml, follicle stimulating hormone (FSH) < 20 mIE/ml and estradiol (E2) > 20 pg/ml. Endocrine therapy will start after the end of chemotherapy. All patients with breast conserving therapy or more than 3 axillary lymph node metastases or in the following cases after mastectomy: - T3/T4-carcinoma - T2-carcinoma > 3 cm - multicentric tumor growth - lymphangiosis carcinomatosa or vessel involvement - involvement of the pectoralis fascia or a safety margin < 5 mm. will receive adjuvant radiotherapy.
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
The purpose of this study is to find out the effects, good and/or bad, of a beta blocker (carvedilol) on heart function during treatment with anti-HER2 medication(s) including trastuzumab (Herceptin).
Most young breast cancer patients undergo chemotherapy and/or endocrine therapy, treatments that impair ovarian function and result in significant reproductive health late effects. These late effects include symptoms of estrogen deprivation (e.g., hot flashes and vaginal dryness), which are distressing in young breast cancer survivors (YBCS). The goal of this pilot study is to test the feasibility of a 4-week text message based intervention on hot flashes and vaginal dryness in YBCS. YBCS will be randomized in a 1:1 ratio to the intervention (text messages on hot flash and vaginal dryness management) and control arms. All participants will be prompted to provide daily hot flash frequency and severity via text messaging. The primary hypothesis is YBCS will have high rates of daily hot flash reporting via text messaging. Secondarily, we will compare changes in hot flash frequency, hot flash severity and vagina dryness between the intervention and control arms.
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization. In this study, our hypothesis are as following: 1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. 2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
Nearly three million living women have survived breast cancer. Physicians rely on clinical practice guidelines to make decisions on follow-up care. Among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. It is unclear whether these guidelines represent the best approach for any given patient as they do not account for differences in disease or patient preferences and may not consider recent advances in imaging and treatment options. We seek to develop a new approach to surveillance following breast cancer treatment which will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors.
This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages. In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.
This study will look at whether or not participating in a physical activity intervention during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a large increase after chemotherapy.