Breast Cancer Clinical Trial
Official title:
Neoadjuvant Dalpiciclib Plus Letrozole for HR+/HER2- Breast Cancer: A Single Arm, Open Label, Phase II Trial
Verified date | August 2022 |
Source | The Affiliated Hospital of Qingdao University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this single arm, open label, phase 2 trial, operable patients with stage IIB-III HR+/HER2- breast cancer will be enrolled and receive six cycles of adjuvant dalpiciclib plus letrozole. This study aims to assessed the biological effects and safety of dalpiciclib in combination with letrozole for HR+/HER2- breast cancer in the neoadjuvant setting.
Status | Not yet recruiting |
Enrollment | 35 |
Est. completion date | May 2024 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Postmenopausal, premenopausal or perimenopausal women aged =18. Postmenopausal was defined as: 1) received bilateral oophorectomy, or aged =60; 2) aged <60, reached natural menopause (defined as no menses for 12 or more consecutive months with no other reason for the amenorrhea), and with postmenopausal E2 and FSH level; 3) premenopausal or perimenopausal women may also be enrolled as long as they are willing to receive LHRH agonist therapy during the study; Operable patients with ER+ (>10%), HER2- invasive breast carcinomas, regardless of PR level. HER2- was defined as IHC score of 0+, or IHC score of 2+ with negative ISH (amplification ratio <2.0) according to 2018 ASCO-CAP guideline; Untreated patients with stage IIB-III according to AJCC criteria (8th edition); Without known hypersensitivity to the study drug or its excipients; A ECOG PS score of 0-1; With the ability to swallow the study drug; With sufficient organ function, including 1) bone marrow function: ANC = 1.5 x 109/L (without growth factors within 14 days); PLT = 100 x 109/L (without corrective therapy within 7 days); Hb = 100 g/L (without corrective therapy within 7 days); 2)liver and kidney function: TBIL = ULN; ALT and AST = 3 × ULN (ALT and AST = 5 × ULN for those with liver metastases); BUN and Cr = 1.5×ULN, and creatinine clearance = 50 mL/min (Cockcroft-Gault formula); 3) QT interval = 480 ms from the 12-lead electrocardiogram; Able to undergo all puncture biopsies required by the protocol; Volunteered to participate in this study; signed informed consent; with good compliance and willingness to follow-up; Exclusion Criteria: Previously treated patients, including chemotherapy, radiotherapy, targeted therapy or endocrine therapy, etc.; Concurrently receiving any anti-tumor treatments other than that prescribed by the protocol; Patients with bilateral breast cancer, inflammatory breast cancer or occult breast cancer; Patients with stage IV breast cancer; Patients with severe liver, kidney, or heart dysfunction; Inability to swallow, with chronic diarrhea, with intestinal obstruction, or with other factors affecting drug administration and absorption; Participated in other clinical trials within 4 weeks before enrollment; Known hypersensitivity to the study drug or its excipients; history of ;immunodeficiency, including HIV positive, HCV positive, active viral hepatitis B, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; History of any cardiac disease, including: 1) arrhythmias requiring drug treatment or of clinical significance; 2) myocardial infarction; 3) heart failure; 4) any other cardiac disease to be inappropriate for this trial judged by the investigator; Women who are pregnant or breastfeeding, women of childbearing potential who test positive for pregnancy test at baseline, or women of childbearing potential who are unwilling to use effective contraception during the study; With serious concomitant disease that endanger safety, or interferes with the ability to complete the study judged by the investigator (including, but not limited to, uncontrolled hypertension, severe diabetes, active infection, etc.); History of neurological or psychiatric disorders, including epilepsy or dementia; or any other condition inappropriate for this study deemed by the investigator. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Hospital of Qingdao University | Jiangsu HengRui Medicine Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete cell-cycle arrest at C1D15, defined as ki67=2.7% | From the date into this study(signed ICF) to C1D15,defined as ki67=2.7% | up 2 years | |
Secondary | residual cancer burden | The percentage of residual tumors after neoadjuvant therapy is assessed according to breast tumor bed tumors and regional lymph nodes | up 2 years | |
Secondary | objective response rate | The rate of CR and PR,determined using RECIST v1.1 criteria | up 2 years | |
Secondary | change in Ki67 from baseline to 2 weeks of treatment | change in Ki67 from baseline(From the date into this study(signed ICF) ) to 2 weeks of treatment | up 2 years | |
Secondary | preoperative endocrine prognostic index | Prognostic indicators of preoperative endocrine therapy, including mass size after neoadjuvant endocrine therapy, lymph node status, ki67 levels, and estrogen receptor (ER) status | up 2 years | |
Secondary | pathologic complete response | After neoadjuvant therapy, there are no residual invasive tumors in the primary focus and regional lymph nodes of breast cancer, but ductal carcinoma in situ may be present(ypT0/is ypN0) | up 2 years | |
Secondary | breast-conserving surgery rate | The number of cases that actually underwent breast-conserving surgery after surgery accounted for the percentage of all breast cancer patients who underwent surgery | up 2 years | |
Secondary | safety profile | Adverse events (AE) and severe adverse events (SAEs) are recorded. Refer to NCI-CTC AE 5.0 standard | up 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |