Comparing the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2019/09/021333
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient is an adult female 18 years old to 60 years old at the time of informed consent. Written informed consent must be obtained
prior to any screening procedures
2. Patient has a histologically and or cytologically confirmed diagnosis of estrogen receptor positive and or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. ER should be more than 10 percent ER
positive or Allred more than or equal to 5 by local laboratory testing.
3. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1 or 2. If IHC is 2, a
negative in situ hybridization FISH, CISH, or SISH test is required by local laboratory testing and based on the most recently analyzed
tissue sample.
4. Women with advanced locoregionally recurrent or metastatic breast cancer not amenable to curative therapy. Patients must fulfill at least
one of the following criteria to be considered that combination chemotherapy is needed according to PIs judgment
Symptomatic visceral metastases
Rapid progression of disease or impending visceral
compromise.
Markedly symptomatic non visceral disease if the treating physician opt to give chemotherapy for rapid palliation of patients symptoms.
5. Patient is premenopausal or perimenopausal at the time of study entry.
a. Premenopausal status is defined as either:
• Patient had last menstrual period within the last 12 months.
OR
• If on tamoxifen within the past 14 days, plasma estradiol must be more than 10 pg/mL and or FSH less than 40 IU/l or in the premenopausal range, according to local laboratory definition.
In case of therapy induced amenorrhea, with a plasma estradiol more than 10 pg/mL and or FSH less than 40 IU/l or in the premenopausal range according to local laboratory
definition.
Patients who have undergone bilateral oophorectomy are not eligible.
b. Perimenopausal status is defined as neither premenopausal nor postmenopausal
6. Patients must have not received any prior hormonal therapy and chemotherapy for advanced breast cancer, except LHRH agonist.
Patients who received less than 14 days of tamoxifen or a NSAI (letrozole or anastrozole) with or without LHRH agonist for advanced breast cancer prior to randomization are eligible. Patient must have measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target
lesion if there is a clear sign of progression since the irradiation)
1. Patient has received prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy, or any CDK4 6 inhibitor for
advanced breast cancer.
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included aromatase inhibitors, the disease free interval must be greater
than 12 months from the completion of aromatase inhibitor treatment until randomization.
Patients who are receiving less than 14 days of tamoxifen or NSAI or LHRH agonists less than 28 days for advanced breast cancer prior to
randomization are eligible.
2. Patient has received extended field radiotherapy or limited field radiotherapy less than 2 weeks prior to randomization, and has not recovered to grade 1 or better from related side effects of such therapy with the
exception of alopecia or other toxicities not considered a safety risk for the patient at investigators discretion. Patient from whom more than 25 percent of the bone marrow has been previously irradiated are also excluded.
3. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal or
squamous cell skin carcinoma non melanomatous skin cancer or curatively resected cervical cancer.
Note CNS involvement must be ruled out by assessments if a patient has
any signs or symptoms indicating potential central nervous system metastases.
4. Patients who have lung metastases with oxygen demand in resting status.
5. Patients who have liver metastases with bilirubin more than 1.5 mg/dL
6. Patients with CNS involvement unless they meet ALL of the following
criteria
At least 4 weeks from prior therapy completion including radiation and or surgery to starting the study treatment.
Clinically stable CNS tumor at the time of screening and not receiving steroids and or enzyme inducing anti epileptic medications for brain metastases.
Leptomeningeal metastases is not allowed, even with stable clinical condition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether treatment <br/ ><br>with NSAI plus goserelin plus ribociclib prolongs PFS compared to treatment with combination chemotherapy in premenopausal or perimenopausal women with <br/ ><br>HR positive, HER2 negative locally advanced or metastatic breast cancer.Timepoint: Progression-free survival is defined as the <br/ ><br>time from the date of randomization to the <br/ ><br>date of the first documented progression as <br/ ><br>per local review and according to RECIST <br/ ><br>1.1 or death due to any cause. <br/ ><br>
- Secondary Outcome Measures
Name Time Method