Study of Abemaciclib in patients with Breast Cancer
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: null- Patients with Breast Cancer
- Registration Number
- CTRI/2017/10/010017
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
[1] Female or male =18 years of age (or of an acceptable age according to local regulations, whichever is older).
[2] The patient has confirmed HR+, HER2-negative (HER2-), early stage resected invasive breast cancer without evidence of distant metastases
[3] The patient must have undergone definitive surgical treatment for the current malignancy.
[4] The patient must have tumor tissue for biomarker analysis available prior to randomization. Preference is for tumor tissue collected prior to exposure to systemic therapy
[5] The patients must fulfill one of the following criteria based on timing of
definitive breast surgery:
A. Patients who have received definitive breast surgery as their initial treatment and are node positive
B. Patients who have received neoadjuvant treatment (chemotherapy or
endocrine therapy) prior to definitive breast surgery
[6] The patient must be randomized within 12 weeks of completion of last non-endocrine treatment (surgery, chemotherapy, or radiotherapy).
[7] If the patient is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 8 weeks prior to randomization.
Neoadjuvant endocrine therapy does not count towards the maximum duration of 8 weeks prior to randomization. Note: Adjuvant treatment with fulvestrant is not allowed.
[8] Patients who received adjuvant chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade =1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral
neuropathy prior to randomization. Patients who are not candidates for adjuvant chemotherapy or decline chemotherapy are permitted. Patients may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization (provided the patient did not receive radiotherapy).
[9] Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
[10] The patient has recovered from surgical side effects following definitive breast surgery based on investigator discretion (for example, adequate wound healing complications or seroma complications).
[11] Women regardless of menopausal status.
[12] Women of reproductive potential (also including women on ovarian suppression with a GnRH agonist) must have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use highly effective contraceptive methods to prevent pregnancy during the study and for 12 weeks following the last dose of study treatment. Males must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 12 weeks following the last dose of study treatment.
[13] The patient has a performance status =1 on the Eastern Cooperative Oncology Group scale
[14] The patient is able to swallow oral medications.
[15] The patient has given written informed consent prior to any study-specific procedures and is willing and able to make herself/himself available for the duration of the study and amenable and able to follow study schedule during treatment and follow-up.
1. The patient has Stage IV (M1), Stage IA, and lymph node-negative breast cancer
2. The patient has a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years. For patients with a history of other cancers within 5 years and considered of very low risk of recurrence per investigator’s judgment (for example, papillary thyroid cancer treated with surgery), eligibility is to be discussed with Study Medical Monitor. Patients with a history of previous breast cancer are excluded, with the exception of LCIS or contralateral ductal carcinoma in situ treated by locoregional therapy alone =5 years ago.
3. Females who are pregnant or lactating.
4. The patient has previously received treatment with any CDK4 and CDK6 inhibitor.
5. The patient is receiving concurrent exogenous hormone therapy. Appropriate washout period between last dose of exogenous hormone therapy and randomization is up to the investigator’s medical judgment (for example, applying 5 times the half-life elimination rule.
6. The patient has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
7. The patient has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
8.The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: patients with controlled atrial fibrillation for >30 days prior to randomization are eligible.
9. The patient has active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity orwith known active hepatitis B or C [for example, hepatitis B surface antigen positive]. Screening is not required for enrollment.
10. The patient has had surgery within 14 days
11.The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization (for Japan, 4 months), or is currently enrolled in any other type of medical research (for example: medical device) judged not to be scientifically or medically compatible with this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy, in terms of IDFS, for patients <br/ ><br>with HR plus, HER2- early stage breast cancer for abemaciclib plus adjuvant endocrine therapy versus adjuvant endocrine therapy aloneTimepoint: Review of IDFS as defined by the STEEP System after 4.75 years
- Secondary Outcome Measures
Name Time Method To assess the safety profile of abemaciclib plus adjuvant <br/ ><br>endocrine therapy compared to adjuvant endocrine therapy aloneTimepoint: Safety review in approximately every 6 months <br/ ><br>;To evaluate health status to inform decision modeling <br/ ><br>for health economic evaluation using the EQ-5D-5L.Timepoint: Review after 4.75 years;To evaluate the efficacy of abemaciclib plus adjuvant <br/ ><br>endocrine therapy versus adjuvant endocrine therapy <br/ ><br>alone in terms of DRFS and OSTimepoint: Review of DRFS and OS after 4.75 years;To evaluate the efficacy, in terms of IDFS, for patients <br/ ><br>with HR plus, HER2-early stage breast cancer with Ki67 <br/ ><br>index =20%Timepoint: Review after 4.75 years;To evaluate the relationship between abemaciclib, <br/ ><br>exposure and clinical (efficacy and safety) outcomesTimepoint: Review after 4.75 years