Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer

ClinicalTrials.gov Identifier: NCT03839823

Novartis Reference Number: CLEE011A3201C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer

Condition 
Breast Cancer
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
222 participants
Start date 
Feb 25, 2019
Completion date 
Oct 31, 2022
Gender 
Female
Age(s)
18 Years - 59 Years (Adult)

Interventions

Combination Product
Docetaxel / Capecitabine
Docetaxel (IV Infusion) / Capecitabine (Tablets for oral use): Docetaxel once, on day 1 of the 3-weeks cycle Capecitabine twice daily, on Days 1 to 14, followed by a 1-week rest period, in 3 weeks cycle. Docetaxel (60 - 75 mg/m²)/capecitabine (1600 - 2500 mg/m²)
Combination Product
Capecitabine / Vinorelbine
Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion ) Capecitabine twice daily on day 1 to 14, followed by a 1-week rest period, in 3 weeks cycle Vinorelbine, once, on Day 1 and Day 8 in 3 weeks cycles Capecitabine (1600 - 2500 mg/m2/day)/vinorelbine (60 to 80 mg/m2 [oral] or (25 to 30 mg/m2 [IV infusion]
Combination Product
Paclitaxel / Gemcitabine
Paclitaxel (IV Infusion) / Gemcitabine (IV Infusion): Paclitaxel via 3-hour intravenous (IV) infusion on Day 1 in 3-weeks cycles, OR Paclitaxel via 1 hour intravenous (IV) infusion on Day 1 and day 8- in 3-weeks cycles. Gemcitabine at via 30 minute IV infusion on Day 1 and Day 8 in 3 weeks cycles. Paclitaxel (175 mg/m2) (on Day 1 in 3-weeks cycles)/ gemcitabine (1000 - 1250 mg/m2/day) OR Paclitaxel (80 - 90 mg/m2) (on Day 1 and Day 8 in 3-weeks cycles) / gemcitabine (800 - 1250 mg/m2)
Drug
Ribociclib
dose: 600 mg (200 mg * 3) Days 1 to 21 of each 28 day cycle Tablets for oral use
Drug
Letrozole OR Anastrozole
Letrozole: Dose: 2.5 mg All days of every cycle without interruption). Tablets for oral use Anastrozole: dose: 1 mg All days of every cycle without interruption. Tablets for oral use The NSAI (letrozole or anastrozole) will be decided by the treating physician.
Drug
Goserelin
dose: 3.6 mg Day 1 of each 28 day cycle (regardless of ribociclib treatment cycle). Subcutaneous implant
Combination Product
Capecitabine / Vinorelbine
Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion ) Capecitabine twice daily on days 1 14, followed by a 1-week rest period, in 3 weeks cycle Vinorelbine, once, on Day 1 and Day 8 in 3 weeks cycles Capecitabine (1600 - 2500 mg/m2/day)/vinorelbine (60 to 80 mg/m2 [oral] or (25 to 30 mg/m2 [IV infusion]
Combination Product
Paclitaxel / Gemcitabine
Paclitaxel (IV Infusion) / Gemcitabine (IV Infusion): Paclitaxel via 3-hour intravenous (IV) infusion on Day 1 in 3-weeks cycles, OR Paclitaxel via 1 hour intravenous (IV) infusion on Day 1 and day 8- in 3-weeks cycles. Gemcitabine at via 30 minute IV infusion on Day 1 and Day 8 in 3 weeks cycles. Paclitaxel (175 mg/m2)/ gemcitabine (1000 - 1250 mg/m2/day) OR Paclitaxel (80 - 90 mg/m2)/ gemcitabine (800 1000 mg/m2)

Eligibility Criteria

INCLUSION CRITERIA

Patient is an adult female ≥ 18 years old and < 60 years old at the time of informed consent.
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% ER positive or Allred ≥5 by local laboratory testing.
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

Women with inoperable locally advanced 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 PI's 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.

Patient is premenopausal or perimenopausal at the time of study entry.

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 and FSH are in the premenopausal range, according to local laboratory definition.
In case of therapy induced amenorrhea, plasma estradiol and/or FSH are in the premenopausal range according to local laboratory definition.
Patients who have undergone bilateral oophorectomy are not eligible.
Perimenopausal status is defined as neither premenopausal nor postmenopausal
Patients must have not received neither prior hormonal therapy nor chemotherapy for advanced breast cancer, except LHRH agonist. Patients who received ≤ 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.

EXCLUSION CRITERIA;

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 treatment free interval must be greater than 12 months from the completion of aromatase inhibitor treatment until randomization.
If patients have disease recurrence during adjuvant tamoxifen treatment, disease free interval (defined as duration between the date of patient received complete tumor resection for primary breast cancer lesion to the date of disease recurrence documented) must be greater than 12 months.
Patients who are receiving ≤ 14 days of tamoxifen or NSAI or LHRH agonists ≤ 28 days for advanced breast cancer prior to randomization are eligible.
Patient has received extended-field radiotherapy or limited field radiotherapy ≤ 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 investigator's discretion). Patient from whom ≥ 25% of the bone marrow has been previously irradiated are also excluded.
Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ.
Patients who have lung metastases with oxygen demand in resting status.
Patients who have liver metastases with bilirubin > 1.5 ULN.

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 Locations

Egypt
Novartis Investigative Site
Recruiting
Cairo, 11566
-
Egypt
Novartis Investigative Site
Recruiting
Cairo, 12655
-
Egypt
Novartis Investigative Site
Recruiting
Cairo,
-
Egypt
Novartis Investigative Site
Recruiting
Giza, 11451
-
Egypt
India
Novartis Investigative Site
Recruiting
Hyderabad, 500018
Andhra Pradesh
India
Novartis Investigative Site
Recruiting
Bangalore, 560 095
Karnataka
India
Novartis Investigative Site
Recruiting
Kolkata, 700099
West Bengal
India
Novartis Investigative Site
Recruiting
Mumbai, 400 012
-
India
Novartis Investigative Site
Recruiting
New Delhi, 110029
-
India
Jordan
Novartis Investigative Site
Recruiting
Amman, 11941
-
Jordan
Lebanon
Novartis Investigative Site
Recruiting
Beirut, 1107 2020
-
Lebanon
Novartis Investigative Site
Recruiting
Beirut, 6301
-
Lebanon
Novartis Investigative Site
Recruiting
Saida, 652
-
Lebanon
Malaysia
Novartis Investigative Site
Recruiting
Johor Bahru, 81100
Johor
Malaysia
Novartis Investigative Site
Recruiting
Kota Kinabalu, 88586
Sabah
Malaysia
Novartis Investigative Site
Recruiting
Kuching, 93586
Sarawak
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 50586
Wilayah Persekutuan
Malaysia
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 111123
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115478
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 143423
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 197758
-
Russian Federation
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169610
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 188770
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 217562
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 258499
-
Singapore
South Africa
Novartis Investigative Site
Recruiting
Durban, 4091
Kwazulu Natal
South Africa
Novartis Investigative Site
Recruiting
Pretoria, 0081
-
South Africa
Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung City, 83301
-
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40447
-
Taiwan
Novartis Investigative Site
Recruiting
Tainan, 70403
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10449
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 11217
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 114
-
Taiwan
Novartis Investigative Site
Recruiting
Taoyuan, 33305
-
Taiwan
Thailand
Novartis Investigative Site
Active, not recruiting
Songkhla, 90110
Hat Yai
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10310
-
Thailand
Novartis Investigative Site
Active, not recruiting
Bangkok, 10400
-
Thailand
Novartis Investigative Site
Active, not recruiting
Chiang Mai, 50200
-
Thailand
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06520
-
Turkey
Novartis Investigative Site
Recruiting
Antalya, 07059
-
Turkey
Novartis Investigative Site
Recruiting
Cankaya Ankara, 06560
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34381
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34662
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey
Novartis Investigative Site
Recruiting
Kecioren Ankara, 06010
-
Turkey
Novartis Investigative Site
Recruiting
Malatya, 44280
-
Turkey
Vietnam
Novartis Investigative Site
Recruiting
Hanoi, 100000
-
Vietnam

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]