A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001)
The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC 1+ or 2+ and ISH-) and hormone receptor-negative(ER-, PR-) breast cancer with residual disease after neoadjuvant treatment. Patients will be randomized 1:1 to either the Experimental arm (combination of AST-301/rhuGM CSF and standard adjuvant therapy) or the Control arm (combination of placebo/rhuGM CSF and standard adjuvant therapy). Standard adjuvant chemotherapy will be pembrolizumab or capecitabine. Adjuvant therapy will be administered in compliance with the NCCN guideline for breast cancer (Version 8, 2021), and IP (AST-301) will be administered 3 times every 3 weeks in the adjuvant treatment period, with a booster administered at 24 weeks (±7 days) post the third dose of IP administration. Survival follow up will be performed to determine invasive Disease Free survival(iDFS).
NCT05163223 — Breast Cancer
Status: Terminated
http://inclinicaltrials.com/breast-cancer/NCT05163223/
Exploring the Link Between Cancer Genetics and Persistent Post-surgical Pain (PPSP) Following Breast Cancer Treatment
Pain is common in cancer, affecting between 40 and 60% of patients depending on tumour type and stage of disease, and represents a major area of unmet need in cancer survivors. Despite advances in treatment, there has been no significant reduction in those who experience pain. Breast cancer is common. It represents 10% of newly diagnosed cancers globally and is often associated with pain. Exact physiological mechanisms for cancer pain are not yet fully established. There is a complex relationship between a malignant lesion and its micro-environment; a tumour does not exist in isolation but has a dynamic relationship with host cells. There is a growing interest in delineating the relationship between tumour manifestations and pain. By retrospectively identifying individuals who have been referred to specialist pain clinics at a cancer centre and matching them to controls, the investigators can identify two groups of patients (those who experienced significant problems with pain and those who did not). Accessing paraffin-embedded tissue samples from those that have had surgical resections, will allow the investigators to compare tissue samples, in particular the metabolic and genetic differences, between the two groups. No new tissue samples will be required for this study. Pain is a major area of unmet need in cancer survivors. The investigators propose that this project would provide valuable knowledge and pilot data regarding the link between pain and tumour genetics. It has the potential to identify tumour genes or mutations that are associated with greater incidences of pain and ultimately potentially guide targeted interventions to help reduce the frequency and impact of pain on patients living with and beyond cancer.
NCT04007861 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT04007861/
Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors
This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.
NCT03523195 — Sedentary Lifestyle
Status: Completed
http://inclinicaltrials.com/sedentary-lifestyle/NCT03523195/
Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Breast Cancer
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.
NCT03240224 — Advanced Breast Cancer
Status: Completed
http://inclinicaltrials.com/advanced-breast-cancer/NCT03240224/
A Continuing Cancer Service Model Emphasizing on Functional Restoration: Model for Breast Cancer
Background and Purposes: Cancer is the leading cause of our mortality. It threatens people's life and quality of life (QOL). Although the incidence of cancer is still rising, with the promotion of cancer screening and progression of medical technology, its survival rate is improving. However, the sequels from cancer or its treatment and the side effects impact the patients along with their lives. Breast cancer is the most incident cancer in women with high survival rate, continuing care after the diagnosis and treatment is much more needed. This study is using breast cancer as an example to establish a continuing service model. This study aims (1) to establish a tailored, continuing care model which emphasizes on breast cancer patients' function. (2) To investigate the effectiveness of the new care model comparing with the control. (3) To find a cutting point of bioelectrical impedance to identify late development of lymphedema. Methods: This is a randomized-controlled trial expanding for 3 years. Women being newly diagnosed with breast cancer and first OPD visit after operation at National Taiwan University Hospital will be invited to join the surveillance and care system. Exclusion criteria are: younger than 20 years old, stage IV, recurrent or both sides involved, with other cancer diagnosis, functional impairments from previous injury or operation on the affected upper extremity and other physical or mental problem to influence the test or filling the questionnaire. It is estimated there will be 100 subjects participate this study every year. After the initial evaluation, they will be randomly allocated to surveillance group (SG) or general care group (CG). Totally, in this three-year study, there will be 200 subjects (100/group), follow-up for 0.5 to 2 years. SG will have health education brochure and free class from the first visit post-operatively but CG will only have the brochure. Moreover, SG will be screened every time when they visit the clinics. If there is any early sign of impairment, professional advice and counseling will be given additionally. In these visits, if CG raises any health-related question, they can be answered. Detailed physical examination to identify their impairments and QOL are at 3, 6, 12, 18, 24 months after operation for both groups. Patients' characteristics, functional status, QOL will be presented by descriptive statistics. T-test/Mann-Whitney U test will be used to compare the differences between patients in two groups. Survival analysis and log-rank test will be used to show the prevalence of various functional impairments and test their difference. ROC curve will be used to find the cutting point for prediction of lymphedema. Expected Results: It is expected (1) to set up the education program and brochure for breast cancer patients. (2) to establish a continuing surveillance and care model for breast cancer patients and extending to all cancers. (3) Women in the new care model will have less impairment and higher QOL comparing with women at the same post-operative stage. (4) To find out the prevalence of functional impairments from the data of control group. (5) A cutting point of bioelectrical impedance to identify late development of lymphedema will be found. (6) To train the team members of cancer care and research.
NCT01963572 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT01963572/
A Prospective, Randomized Controlled Trial of Mindfulness-based Stress Reduction (MBSR) Among Women Operated for Breast Cancer
The number of Danish women treated for breast cancer rise every year, though survival rates have improved, women can still expect to experience the diverse late effects reported by this group of patients. Mindfulness labels the ability to be aware of the present moment - thereby avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR) is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The program aims at developing participants' coping resources and developing participants' mindful awareness. Thus the program consists of guided meditations, guided body scan(a specific awareness exercise)and through meditation, yoga and psychoeducation concerning stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found positive effects of the program among cancer patients. The investigators want to evaluate the effect of the MBSR program on levels of anxiety and depression as well as the possible influence of mindfulness training on health behaviors and existential concerns. The study are based on the following hypotheses: - report of anxiety and depression will decrease among cases - better compliance will lead to more decrease in levels of anxiety and depression - cases will make lifestyle changes suitable with recommendations for BC patients in post-treatment phase of the illness - decreased level of anxiety and depression will reflect improved spiritual well-being - improved spiritual wellbeing will lead to decreased report of physical symptoms All participants in this randomized controlled trial will fill out questionnaires at enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians and patients will be able to make decisions regarding post-treatment psychosocial intervention and researchers will have initial evidence of the effect of the intervention and thus possible indications for research on mindfulness among patients diagnosed with cancer at other stages or sites.
NCT00990977 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00990977/
A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen. PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.
NCT00083174 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00083174/
Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors
This study is funded by the HEAL Initiative (https://heal.nih.gov/). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.
NCT06085313 — Depressive Symptoms
Status: Recruiting
http://inclinicaltrials.com/depressive-symptoms/NCT06085313/
Comparison of Breast Cancer Screening With Dual-Energy Contrast-Enhanced Spectral Mammography to Digital Breast Tomosynthesis in Women With Dense Breasts (Contrast Mammography Imaging Screening Trial
The over-arching goal of the Contrast-Enhanced Spectral Mammography Imaging Screening Trial (CMIST) is to determine if dual-energy contrast-enhanced spectral mammography (CESM) can detect more cancers with fewer false positives than digital breast tomosynthesis (DBT) in women with dense breasts. Aim 1: To evaluate the performance of CESM compared to DBT at baseline for breast-cancer screening in women with dense breasts. Aim 2: To evaluate the performance of CESM compared to DBT at the 1-year follow up for breast-cancer screening in women with dense breasts.
NCT05625659 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05625659/
Women with primary breast cancer may benefit from participating in supports groups as they cope with treatment and the psychological challenges of survivorship. Studies have documented that these women benefit from support groups run in a university setting; however, no one has documented that they benefit from community cancer support groups. Many community cancer support groups exist and provide service to a large number of women with breast cancer. It is important to know if these groups are providing comparable service to well researched support groups. We conducted this study as the first randomized study of community compared to university-style support groups. Women had a 50/50 chance of being assigned to either a community or a university style support group based on a coin flip. This study took place in two sites The Wellness Community East Bay (Walnut Creek) and San Francisco. Two community groups were studied. i) This study evaluated the strengths and weaknesses of two community-based support group interventions for breast cancer patients [The Wellness (TWC) and Cancer Support (CSC) Communities, in the San Francisco area]. We compared them with a type of therapy developed in the university setting (Stanford's Supportive-Expressive group therapy), studied which aspects are most effective, and who benefits the most. We compared these women on change in emotional distress, means of coping with cancer, and social and family support. In addition, change in physiological response to stress was measured using saliva samples. ii) We were able to achieve recruitment for 6 of 8 groups proposed. We randomized 72 women in blocks of 12 taking consecutive women per site until we accrued 12 for each group. Of those, 61 women actually attended groups, of those 46 women to date completed at least one follow-up and were available for analysis for this report. We screened 108 women, 16 who were screened out on initial phone contact, 20 women began to go through our baseline interviews and assessments and either decided not to enroll or dropped out before we could compose a group for the second S.F. randomization. Our final two follow-up assessments for our final group in the East Bay are being conducted right now (8 month) and will be conducted in October, 2002 (12 month) so they are not available for assay or analysis for this final report. iii) We examined 5 outcome variables for this report and found that women participating in the community groups changed at about the same level over the 4 months of group therapy as the women in the Stanford groups. This was true for depression symptoms, trauma symptoms, social support, self-efficacy, and post-traumatic-growth. These analyses are preliminary until we complete our final follow-up assessments. It is encouraging for the community groups that women benefited at the same rate as they did in the well-researched Stanford groups. Conclusions for this study are somewhat limited because we could not complete the recruitment of our entire sample. However, there is every reason to suppose that community groups are as effective at serving women with primary breast cancer as Stanford's groups though they are based on very different ideas of therapy. It is important to note that all of these groups were led by therapists, and that we may have found other results if the groups had been led by peers or other types of professionals. This study reduces the human and economic cost of breast cancer in California by validating community groups usually offered free to women with breast cancer.
NCT00186524 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT00186524/