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Carcinoma, Ductal, Breast clinical trials

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NCT ID: NCT04169542 Recruiting - COVID-19 Infection Clinical Trials

Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery

Start date: May 21, 2019
Phase:
Study type: Observational

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.

NCT ID: NCT04144023 Recruiting - Clinical trials for Breast Ductal Carcinoma In Situ

A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

Start date: June 27, 2019
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.

NCT ID: NCT04088435 Terminated - Breast Cancer Clinical Trials

Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer

Start date: September 10, 2019
Phase:
Study type: Observational [Patient Registry]

Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal of this study is to report acute and late toxicities and cosmetic outcomes following breast IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy. The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated with a lower rate of physician reported acute side effects than traditional whole breast radiation therapy after lumpectomy.

NCT ID: NCT04084730 Recruiting - Breast Cancer Clinical Trials

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

Start date: August 30, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.

NCT ID: NCT04046159 Recruiting - Clinical trials for Breast Ductal Carcinoma in Situ

Radiotherapy Versus Low-Dose Tamoxifen Following Breast Conserving Surgery for Low-Risk Breast Ductal Carcinoma in Situ

Start date: April 30, 2019
Phase: Phase 3
Study type: Interventional

Although the results obtained from ECOG E5194 cohort 1 (criteria: mammographically detected low- or intermediate-grade DCIS, measuring less than 2.5 cm with margins ≥ 3 mm) and RTOG 9804 trial (the same enrolled clinicopathological features to cohort 1 of ECOG E5194 trial) demonstrated that the 7-year ipsilateral breast tumor recurrence (IBTR) ranged from 5.6% to 10.5% for low-risk ductal carcinoma in situ (DCIS) patients, the aforementioned two studies included a proportional patients who had young age and negative estrogen receptor (ER) status tumor. Previous studies and our studies revealed that age < 40 years and ER-negative status in tumor were independent prognostic factor for recurrence of breast DCIS irrespective of tumor characteristics. The UK/ANZ randomized trial, enrolling high-risk and low-risk clinicopathologic features of DCIS, demonstrated that a benefit of tamoxifen in terms of reducing the IBTR is observed in the BCS alone group but not found in the BCS plus RT group. A recent published randomized trial showed that tamoxifen at the dose of 5 mg/day for 3 years. Based on the aforementioned results, we hypothesized that the administration of tamoxifen is not inferior than the prescription of RT in terms of reducing the IBTR for DCIS patients who had age more than 40 years, the pathological features meeting the ECOG E5194 cohort 1 criteria, and positive ER status in tumors. To approve the hypothesis, we will design a randomized non-inferiority trial to assess whether the effect of administration of tamoxfien (5 mg per day) for 10 years following BCS is not inferior in terms of reducing IBTR when comparing RT following BCS for patients who had low-risk clinicopathologic features (age more than 40 years and ECOG E5194 cohort 1 criteria) and positive-ER status of breast DCIS.

NCT ID: NCT04022772 Completed - Breast Carcinoma Clinical Trials

Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer

Start date: July 31, 2019
Phase: N/A
Study type: Interventional

This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.

NCT ID: NCT04021069 Active, not recruiting - Breast Cancer Clinical Trials

Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Start date: August 30, 2018
Phase:
Study type: Observational

This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

NCT ID: NCT04009044 Recruiting - Cancer Survivor Clinical Trials

Topical Afimoxifene in Treating Patients With Breast Cancer Who Have Undergone Radiation Therapy on One Breast

Start date: February 17, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well topical afimoxifene works in treating patients with breast cancer who have undergone radiation therapy on one breast. Topical afimoxifene is a quick-drying medicated gel that may block the growth of breast cancer cells when applied to the breast skin. The purpose of this research is to determine what effect, if any, differences in skin type between women have on the delivery of topical afimoxifene to the breast tissue, and whether radiation affects the delivery of topical afimoxifene to breast tissue.

NCT ID: NCT03979508 Recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer

Start date: January 10, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well abemaciclib works in treating patients with triple negative breast cancer that can be removed by surgery (resectable) and does not respond to treatment with chemotherapy alone, or in combination with pembrolizumab. Abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT03947151 Completed - Clinical trials for Invasive Ductal Breast Carcinoma

Efficacy and Tolerance of an Ovarian Stimulation Protocol Combining Follicle Stimulating Hormone (FSH) and Degarelix Acetate in Female Candidates for Fertility Preservation Before Chemotherapy for Breast Cancer

DEGASTIM
Start date: November 28, 2019
Phase: Phase 2
Study type: Interventional

The present investigation aims to evaluate the efficacy of an innovative protocol of controlled ovarian stimulation for breast cancer patients, who are candidates for fertility preservation. Currently, vitrification of oocytes and/or embryos after controlled ovarian stimulation is the most established method for female fertility preservation. However, this stimulation induces an increase in serum estrogen levels, which is theoretically problematic in case of hormone-sensitive tumors such as breast cancer. The majority of oncology teams accept, in very specific situations (particularly when the tumor has been surgically removed), this ovarian stimulation, because the expected benefits of fertility preservation far outweigh the risks. However, everyone agrees that it would be more comfortable to be able to offer vitrification of oocytes and/or embryos using ovarian stimulation without increasing estrogen levels. In this research, investigators will evaluate the efficacy of degarelix (Firmagon®), currently indicated for the treatment of prostate cancer, as an innovative ovarian stimulation procedure. Administered at the beginning of ovarian stimulation, they believe it should maintain serum estradiol levels at physiological values at the end of stimulation.