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Postmenopausal clinical trials

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NCT ID: NCT03953157 Recruiting - Clinical trials for Anatomic Stage II Breast Cancer AJCC v8

Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors

Start date: October 7, 2019
Phase: N/A
Study type: Interventional

This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.

NCT ID: NCT03913234 Recruiting - Clinical trials for Metastatic Breast Cancer

Phase IB & II Study of Ribociclib With Trastuzumab Plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients

Start date: June 10, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Survival benefit and quality of life are two key elements that should be kept in mind in the treatment of metastatic breast cancer. In this regards, endocrine therapy (ET) is strongly recommended in hormone receptor (HR) positive patients unless there is visceral crisis even though there is no concrete evidence that it is better than chemotherapy in terms of survival. HER2 positive breast cancer is a subtype of breast cancer that showed the greatest improvement in terms of survival during the last decade due to trastuzumab based therapy. Recently, taxane and HER2 directed doublet including trastuzumab and pertuzumab (THP) is considered as standard of therapy based upon randomized phase 3 clinical trial (CLEOTATRA). HER2 positive breast cancer can be divided into HER2 enriched subgroup (HR-HER2+) and luminal B subgroup (HR+HER2+) in biologic viewpoint because they are distinctly different subgroups in gene expression analysis. Accordingly, we are currently treating biologically different subtypes in a same way, which is CTx and anti-HER2 combination therapy (THP). Luminal HER2+ subgroup has actually been tested with endocrine therapy (ET) and anti-HER2 therapy showed better PFS than ET alone (TAnDEM trial and trial comparing lapatinib plus letrozole versus letrozole alone) [2],[3] confirming existence of cross talk between ER and HER2 pathways in clinical setting. However, the combination regimen between ET and anti-HER2 therapy is not widely used in current practice in ER+HER2+ MBC patients because PFS seemed to be relatively shorter compared with chemotherapy based combination with anti-HER2 therapy even though several guidelines recommend it to be used as an initial treatment unless there is visceral crisis as they recommended ET alone first in ER+HER2- MBC (NCCN 2018). Recently, various CDK4/6 inhibitors including palbociclib, abemaciclib, and ribociclib were approved by FDA based on the clinical trial results demonstrating prolonged PFS over ET alone when it was combined with ET in ER+ advanced breast cancer [4]. In PALOMA 2 biomarker study, it was beneficial regardless of ER and Ki67 expression status. Reflecting quite durable PFS prolongation (10 month in PALOMA2) shown in ER+ disease (luminal A and luminal B subtype except HR+HER2+ patients) with CDK4/6 inhibitor on top of ET, the hypothesis of this trial is whether CDK4/6 inhibitor could prolong survival in luminal HER2 breast cancer as it did in ER+HER2-patients. In preclinical study, palbociclib showed activity in not only ER+ cell lines but also HER2 positive cell lines [5]. Also, in phase Ib trial, a CDK4/6 inhibitor from Lilly, abemaciclib showed acceptable toxicity with endocrine therapy or trastuzumab with response rate of around 20%. Hence, as of today, it could be justified and warranted to conduct a prospective trial of ribocicib+letrozole+trastuzumab in order to take a look at its efficacy and toxicity in HR+HER2 + advanced breast cancer.

NCT ID: NCT03756272 Completed - Postmenopausal Clinical Trials

Stellate Ganglion Block to Reduce Hot Flushes

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

NCT ID: NCT03708055 Completed - Overweight Clinical Trials

Weight Bearing Exercise in Preventing Frailty in Stage I-IIIA Breast Cancer Survivors

Start date: July 24, 2008
Phase: N/A
Study type: Interventional

This trial studies how well weight bearing exercise works in preventing frailty in stage I-IIIA breast cancer survivors. Weight bearing exercise, including muscle-strengthening, aerobic, flexibility, and balance exercises, can decrease fat and increase muscle, which may lead to reduced frailty.

NCT ID: NCT03238703 Withdrawn - Clinical trials for Invasive Breast Carcinoma

Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

Start date: September 1, 2018
Phase: Phase 4
Study type: Interventional

This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.

NCT ID: NCT03180294 Completed - Breast Carcinoma Clinical Trials

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

Start date: May 31, 2017
Phase: Phase 2
Study type: Interventional

This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.

NCT ID: NCT03128619 Terminated - Clinical trials for Stage IV Breast Cancer

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Start date: August 2, 2017
Phase: Phase 1
Study type: Interventional

This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer. Copanlisib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs, such as letrozole, may lessen the amount of estrogen made by the body. Giving copanlisib, letrozole, and palbociclib may work better in treating patients with breast cancer.

NCT ID: NCT03091842 Withdrawn - Clinical trials for Stage IIIA Breast Cancer

Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer

Start date: July 29, 2019
Phase: N/A
Study type: Interventional

This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors. Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese.

NCT ID: NCT03090997 Active, not recruiting - Insulin Resistance Clinical Trials

Effect of Resveratrol and Vitamin C on Insulin Resistance Among Postmenopausal Women

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Hormonal and metabolic changes because of postmenopause increase body weight, central abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and cardiovascular disease

NCT ID: NCT02860000 Active, not recruiting - Clinical trials for Stage IV Breast Cancer

Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

Start date: July 6, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.