Nds trial

Study record managers: refer to the Data Element Definitions if submitting registration or results information. This study will evaluate and refine the dose and schedule of JCAR to optimize safety and antitumor activity. A dose-confirmation group or groups will further evaluate the safety and efficacy of JCAR at the recommended regimen s. Each cycle will include lymphodepleting chemotherapy followed by one or two doses of JCAR administered by intravenous IV injection.

The follow-up period for each participant is approximately 24 months after the final JCAR infusion. Long-term follow-up for survival, toxicity, and viral vector safety will continue under a separate long-term follow-up protocol per health regulatory authority guidelines, currently up to 15 years after the last JCAR infusion. During JCAR production, participants may receive low-dose chemotherapy for disease control.

Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR administered by intravenous IV injection. Upon product availability, participants will receive study treatment consisting of lymphodepleting chemotherapy followed by two IV doses of JCAR Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort.

Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : June 21, See Contacts and Locations. Communication was always timely.

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For others, lumpectomy breast conservation surgery , will ensure that a only limited amount of breast tissue is removed. Anti-hormone therapy Endocrine treatment after surgery is very effective in the long-term treatment of breast cancer; it is however currently unknown whether it is also beneficial to start this same endocrine treatment before s urgery , known as neo-adjuvant endocrine therapy. This study is to determine whether giving some of the endocrine therapy before surgery will shrink the tumour prior to operating.

This could increase the rates of breast preservation by reducing the number of mastectomies for some women and the extent of surgery for others removing less tissue leaves less defect. After mastectomy, many patients do not want or are unsuitable for breast reconstruction. Even if received, this may not always fully compensate for breast removal. Reducing the amount of breast tissue that has to be removed and increasing the rates of preserving breasts by treatment with neo-adjuvant endocrine therapy is therefore anticipated to improve cosmetic outcomes, leading to better quality of life.