Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 (RIGHT Choice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. 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.
 
ClinicalTrials.gov Identifier: NCT03839823
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Combination Product: Docetaxel / Capecitabine Combination Product: Capecitabine / Vinorelbine Combination Product: Paclitaxel / Gemcitabine Drug: Ribociclib Drug: Letrozole OR Anastrozole Drug: Goserelin Phase 2

Detailed Description:
A phase II randomized study of the combination of Ribociclib plus goserelin acetate with Hormonal Therapy versus physician choice hemotherapy in premenopausal or perimenopausal patients with hormone receptorpositive/ HER2-negative inoperable locally advanced or metastatic breast cancer - RIGHT Choice Study

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, phase II, open label, multi-center trial comparing the combination of NSAI (letrozole or anastrozole) + goserelin + ribociclib versus combination chemotherapy (docetaxel/capecitabine or paclitaxel/gemcitabine or capecitabine/vinorelbine). Premenopausal or perimenopausal women with HR+, HER2- negative, advanced breast cancer with ECOG of 0 to 2 and having symptomatic visceral metastases, or rapid progression of disease or impending visceral compromise, or markedly symptomatic non visceral disease will be considered for this study
Masking: None (Open Label)
Masking Description: Randomized open label study
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Comparator arm
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine will be administer to patients enrolled in the control group. The chemotherapy regimen will be decided by the treating physician.
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)

Other Names:
  • Combination chemotherapy group.
  • The chemotherapy regimen will be decided by the treating physician.

Combination Product: Capecitabine / Vinorelbine

Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion )

Capecitabine twice daily on days 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]

Other Names:
  • Combination chemotherapy group.
  • The chemotherapy regimen will be decided by the treating physician.

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 1000 mg/m2)

Other Names:
  • Combination chemotherapy group.
  • The chemotherapy regimen will be decided by the treating physician.

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]

Other Names:
  • Combination chemotherapy group.
  • The chemotherapy regimen will be decided by the treating physician.

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)

Other Names:
  • Combination chemotherapy group.
  • The chemotherapy regimen will be decided by the treating physician.

Experimental: Ribociclib arm

Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.

  1. Ribociclib (600 mg) is dosed orally for the first 21 days out of a 28 day cycle.
  2. Letrozole (2.5 mg) or anastrozole (1 mg) are dosed orally daily (28 days out of the 28 day cycle).
  3. Goserelin (3.6 mg) is continuously released via a subcutaneous implant injected on Day 1 of each 28 day cycle.
Drug: Ribociclib
dose: 600 mg Days 1 to 21 of each 28 day cycle Tablets for oral use
Other Names:
  • Endocrine treatment arm:
  • NSAI + goserelin+ ribociclib

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.

Other Names:
  • Endocrine treatment arm:
  • NSAI + goserelin+ ribociclib

Drug: Goserelin
dose: 3.6 mg Day 1 of each 28 day cycle Subcutaneous implant
Other Names:
  • Endocrine treatment arm:
  • NSAI + goserelin+ ribociclib




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Up to approximately 12 months ]
    Progression-free survival is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause.


Secondary Outcome Measures :
  1. Time to treatment failure [ Time Frame: Up to approximately 12 months ]
    Time to treatment failure is defined as the time from the date of randomization/start of treatment to the earliest of date of progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'.

  2. Overall response rate (ORR) [ Time Frame: Up to approximately 12 months ]
    Overall response rate (ORR) is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR), as per local review and according to RECIST 1.1.

  3. Clinical benefit rate [ Time Frame: Up to approximately 12 months ]
    Clinical benefit rate is defined as the proportion of patients with a best overall response of CR, or PR or stable disease, lasting for a duration of at least 24 weeks, as defined by RECIST 1.1.

  4. Time to response [ Time Frame: Up to approximately 12 months ]
    Time to response is defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed, as defined by RECIST 1.1.

  5. Overall survival [ Time Frame: Up to approximately 44 months ]
    Overall survival is defined as the time from the date of randomization to the date of death due to any cause.

  6. Frequency/severity of adverse events, lab abnormalities. [ Time Frame: Up to approximately 44 months ]
    Safety of ribociclib in combination with NSAI and goserelin, and combination chemotherapies

  7. Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire [ Time Frame: Up to approximately 44 months ]

    Functional Assessment of Cancer Therapy - Breast (FACT-B) will be collected to assess health-related QoL, health status, functioning, disease symptoms, side effects, and cancer-related pain.

    Descriptive statistics will be used to summarize the overall score at each scheduled assessment time point. Additionally, change from baseline at the time of each assessment will be summarized.

    The distribution of time to definitive 10% deterioration in the global health status from FACT-B questionnaire will be assessed in the two treatment arms. Scores range from 0 to 4. no subscale. 0 score is the worst for social/family and functional wellbeing and 4 is the worst for physical, emotional wellbeing and additional concerns.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. 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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patient is an adult female ≥ 18 years old and < 60 years old at the time of informed consent.
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Patient is an adult female ≥ 18 years old and < 60 years old at the time of informed consent.
  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% ER positive or Allred ≥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
  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 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.
  5. Patient is premenopausal or perimenopausal at the time of study entry.

    1. 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 ≥ 10 pg/mL and/or FSH ≤ 40 IU/l or in the premenopausal range, according to local laboratory definition.
      • In case of therapy induced amenorrhea, with a plasma estradiol ≥10 pg/mL and/or FSH ≤40 IU/l or in the premenopausal range according to local laboratory definition.
      • Patients who have undergone bilateral oophorectomy are not eligible.
    2. 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 ≤ 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;

  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 ≤ 14 days of tamoxifen or NSAI or LHRH agonists ≤ 28 days for advanced breast cancer prior to randomization are eligible.
  2. 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.
  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.
  4. Patients who have lung metastases with oxygen demand in resting status.
  5. Patients who have liver metastases with bilirubin > 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839823


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Layout table for location information
Malaysia
Novartis Investigative Site Recruiting
Johor Bahru, Johor, Malaysia, 81100
Novartis Investigative Site Recruiting
Kota Kinabalu, Sabah, Malaysia, 88586
Novartis Investigative Site Recruiting
Kuching, Sarawak, Malaysia, 93586
Novartis Investigative Site Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Novartis Investigative Site Recruiting
Singapore, Singapore, 188770
Novartis Investigative Site Recruiting
Singapore, Singapore, 217562
Novartis Investigative Site Recruiting
Singapore, Singapore, 258499
Taiwan
Novartis Investigative Site Recruiting
Taichung, Taiwan, 40447
Novartis Investigative Site Recruiting
Tainan, Taiwan, 70403
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10002
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10449
Novartis Investigative Site Recruiting
Taoyuan, Taiwan, 33305
Thailand
Novartis Investigative Site Recruiting
Songkhla, Hat Yai, Thailand, 90110
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10310
Novartis Investigative Site Recruiting
Bangkok, Thailand, 10400
Novartis Investigative Site Recruiting
Chiang Mai, Thailand, 50200
Turkey
Novartis Investigative Site Recruiting
Antalya, Turkey, 07059
Novartis Investigative Site Recruiting
Istanbul, Turkey, 34381
Novartis Investigative Site Recruiting
Izmir, Turkey, 35040
Novartis Investigative Site Recruiting
Malatya, Turkey, 44280
Vietnam
Novartis Investigative Site Recruiting
Hanoi, Vietnam, 100000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03839823     History of Changes
Other Study ID Numbers: CLEE011A3201C
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HR-positive
HER2-negative
advanced breast cancer
Ribociclib
NSAI
Goserelin
Docetaxel / capecitabine
Paclitaxel/gemcitabine
Capecitabine/vinorelbine
CDK4/6
Phase II
ER-positive
PR-positive
Premenopausal
Perimenopausal.
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Paclitaxel
Vinorelbine
Docetaxel
Albumin-Bound Paclitaxel
Capecitabine
Letrozole
Anastrozole
Goserelin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors