Breast CancerPhase 1NCT02586675
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
A Phase 1 study testing Tamoxifen, Ribociclib and Goserelin in people with Breast Cancer and Breast Cancer - Female, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer known as hormone receptor positive/HER2- breast… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- What is being tested?
- Tamoxifen, Ribociclib and Goserelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2016to 27 Oct 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed diagnosis of Estrogen Receptor-Positive (ER+) and/or Progesterone Receptor-Positive (PR+) breast cancer by local laboratory.
- Human Epidermal growth factor Receptor 2 Negative (HER2-) breast cancer defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative In Situ Hybridization (Fluorescence [FISH], Chromogenic [CISH], or Silver [SISH]) test is required by local laboratory testing.
- Participants are allowed (but not required) to have up to two lines of prior chemotherapy regimens in the metastatic setting for the dose expansion phase. For the dose escalation cohort, up to three previous lines of chemotherapy in the metastatic setting is acceptable.
- Measurable disease, i.e., at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria only *for expansion cohorts.
- For *escalation cohorts, bone only disease is allowed. For expansion cohorts, there must be measurable disease as stated above.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
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- Written informed consent must be obtained prior to any screening procedures and according to local guidelines.
- Adequate bone marrow and organ function.
- Must be able to swallow ribociclib and Tamoxifen capsules/tablets.
- Pre-Menopausal Women Eligibility: 1) Pre-menopausal women who received adjuvant Aromatase Inhibitor and Ovarian Suppression (AI + OS) in the adjuvant setting and completed at least 12 months of hormonal therapy. 2) Pre-menopausal women with de novo metastatic disease are eligible if they have had no prior endocrine therapy. 3) Pre-menopausal women who have not received Tamoxifen in the metastatic setting, but have received up to two lines of chemotherapy.
- Post-Menopausal Women and Men Eligibility: 1) Post-menopausal women or men who have progressed on first-line or second line therapy with an aromatase inhibitor in the metastatic setting. 2) Post-menopausal women or men who have recurred while on or after completion of adjuvant treatment with aromatase inhibitors (they have completed at least one year of AI in the adjuvant setting before progression on AI). 3) Post-menopausal women or men who are not considered candidates for treatment with an aromatase inhibitory by their oncologist, patients not willing to go on AI, or patients who were intolerant to AI.
- Post-menopausal women or men are allowed (but not required) to have up to two lines of prior chemotherapy regimens in the metastatic setting for the dose expansion phase . For the dose escalation cohort, up to three previous lines of chemotherapy in the metastatic setting is acceptable.
Who cannot join
- Potential participants with inflammatory breast cancer.
- Prior CDK 4/6 inhibitor exposure.
- Have received Tamoxifen in the metastatic setting (for more than 30 days) or has progressed while on Tamoxifen in the adjuvant setting.
- Known hypersensitivity to ribociclib or excipients of tamoxifen.
- A concurrent malignancy or malignancy within 3 years of starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- Central nervous system (CNS) involvement unless specific criteria are met.
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- Impairment of Gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Known history of HIV infection (testing not mandatory).
- Any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.).
- Clinically significant, uncontrolled heart disease and/or a recent events as specified in the study protocol
- Currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug: a. Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges. b. That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. c. That have a known risk to prolong the QT interval or induce Torsades de Pointes. d. Herbal preparations/medications, dietary supplements not prescribed by an M.D..
- Currently receiving or has received systemic corticosteroids ≤2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
- The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
- Currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
- Participation in a prior investigational study within 30 days prior to enrollment..
- Has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom ≥ 25% of the bone marrow was irradiated.
- Has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
- Has not recovered from all toxicities related to prior anticancer therapies to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade equal to or less than 1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study).
- A Child-Pugh score B or C.
- History of non-compliance to medical regimen or inability to grant consent.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.]
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation. There are specific guidelines regarding the various acceptable highly effective contraception methods. Note: The use of oral contraception is not allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: The TEEL Study: A Phase I Trial of Tamoxifen With Ribociclib (LEE011) in Adult Patients With Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer known as hormone receptor positive/HER2- breast cancer.
Read the detailed description
Phase I Dose Escalation:
The phase I portion of the study is a dose escalation to confirm the safety of the combination and to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) for ribociclib with Tamoxifen.
Phase I will be conducted in all participants with Hormone Receptor Positive (HR+)/Human Epidermal growth factor Receptor 2 Negative (HER2-) locally advanced or metastatic breast cancer with any prior endocrine therapy and up to three prior cytotoxic chemotherapy regimens administered in the metastatic or locally advanced setting.
Phase Ib Dose Expansion:
Phase I trials are increasingly including dose-expansion cohorts (Ib) after the maximum-tolerated dose has been reached to better characterize the toxicity profile and identify early signs of efficacy within this specific disease population. The investigators' goal is to assess the anti-tumor activity Ribociclib + Tamoxifen and to further evaluate their safety in adult patients with HR+/HER2- locally advanced or metastatic breast cancer. Patients in the phase 1b expansion will have the same exclusion and inclusion criteria except that they will only be allowed to have up to two lines of cytotoxic chemotherapy in the metastatic setting.
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Being tested
- Tamoxifen, Ribociclib, Goserelin
- Keywords
- ER+ breast cancer, PR+ breast cancer, hormone receptor positive, HER2- breast cancer, HER2 negative, locally advanced, metastatic
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Tamoxifen will be taken orally once daily on a continuous daily schedule (e.g., days 1-28 of each 28 day cycle).
RibociclibDrug
Also called LEE011, Cyclin-Dependent Kinase (CDK) Inhibitor
Ribociclib (LEE011) will be taken orally once daily on days 1-21 of each 28 day cycle. Days 22-28 will be a "rest" period from dosing with Ribociclib. In the continuous cohort, 400 mg ribociclib will be given daily (QD).
GoserelinDrug
Also called Zoladex, Goserelin acetate
Goserelin will be given as an injectable subcutaneous implant on day 1 of every 28 day cycle. This will be given in pre-menopausal and peri-menopausal women.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen and Ribociclib with Goserelin | Experimental | Phase I dose escalation followed by Phase Ib dose expansion. Tamoxifen and Ribociclib, with Goserelin added for premenopausal or peri-menopausal participants. Ribociclib: Capsules/Tablets for oral use 400 mg OR 600 mg Days 1-21 of each 28 day cycle or daily. Tamoxifen: Tablets for oral use 20 mg daily (all days of every cycle without interruption). Goserelin: Subcutaneous injection 3.6 mg Day 1 of each 28 day cycle. Receives: Drug: Tamoxifen; Drug: Ribociclib; Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RP2D)
400-600 mg of Ribociclib, when taken with Tamoxifen 20 mg. The Phase I portion of the study is a dose escalation to confirm the dose limiting toxicity (DLT) and the RP2D for ribociclib with Tamoxifen. DLT is defined as an adverse event or abnormal laboratory value assessed as having a reasonable possibility related to the study medication, unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) with LEE011 and Tamoxifen. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading. In this study, a DLT will occur if CTCAE grade 4 neutropenia lasts more than 4 consecutive days, if CTCAE grade 3 thrombocytopenia is associated with clinically significant bleeding or if there is grade 4 thrombocytopenia.
Measured: Up to 12 months
Secondary outcomes (2)
Progression-free Survival (PFS) at Six Months
Occurrence of Progression Survival at 6 months. PFS: On study date to date of progression or the same as overall survival time if not progressed. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: 6 months
Overall Survival (OS) at Six Months
Occurrence of Overall Survival at 6 months. OS: On study date to expired date or last visit date if not deceased.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start23 Feb 2016
- Primary completion8 May 2017
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Roohi Ismail-Khan, MD, MSc, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586675
- Sponsor's protocol ID
- MCC-18332
- Status last verified
- Jan 2022
- First submitted
- 23 Oct 2015
- Last updated
- 21 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TEEL Study: A Phase I Trial of Tamoxifen With Ribociclib (LEE011) in Adult Patients With Advanced ER+ (HER2 Negative) Breast Cancer
- ClinicalTrials.gov ID
- NCT02586675
- Acronym / sponsor ID
- MCC-18332
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Keywords
- ER+ breast cancer, PR+ breast cancer, hormone receptor positive, HER2- breast cancer, HER2 negative, locally advanced, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women and men who have a type of breast cancer known as hormone receptor positive/HER2- breast cancer.
Detailed description
Phase I Dose Escalation:
The phase I portion of the study is a dose escalation to confirm the safety of the combination and to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) for ribociclib with Tamoxifen.
Phase I will be conducted in all participants with Hormone Receptor Positive (HR+)/Human Epidermal growth factor Receptor 2 Negative (HER2-) locally advanced or metastatic breast cancer with any prior endocrine therapy and up to three prior cytotoxic chemotherapy regimens administered in the metastatic or locally advanced setting.
Phase Ib Dose Expansion:
Phase I trials are increasingly including dose-expansion cohorts (Ib) after the maximum-tolerated dose has been reached to better characterize the toxicity profile and identify early signs of efficacy within this specific disease population. The investigators' goal is to assess the anti-tumor activity Ribociclib + Tamoxifen and to further evaluate their safety in adult patients with HR+/HER2- locally advanced or metastatic breast cancer. Patients in the phase 1b expansion will have the same exclusion and inclusion criteria except that they will only be allowed to have up to two lines of cytotoxic chemotherapy in the metastatic setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen and Ribociclib with Goserelin | Experimental | Drug: Tamoxifen, Drug: Ribociclib, Drug: GoserelinPhase I dose escalation followed by Phase Ib dose expansion. Tamoxifen and Ribociclib, with Goserelin added for premenopausal or peri-menopausal participants. Ribociclib: Capsules/Tablets for oral use 400 mg OR 600 mg Days 1-21 of each 28 day cycle or daily. Tamoxifen: Tablets for oral use 20 mg daily (all days of every cycle without interruption). Goserelin: Subcutaneous injection 3.6 mg Day 1 of each 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically and/or cytologically confirmed diagnosis of Estrogen Receptor-Positive (ER+) and/or Progesterone Receptor-Positive (PR+) breast cancer by local laboratory.
- Human Epidermal growth factor Receptor 2 Negative (HER2-) breast cancer defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative In Situ Hybridization (Fluorescence [FISH], Chromogenic [CISH], or Silver [SISH]) test is required by local laboratory testing.
- Participants are allowed (but not required) to have up to two lines of prior chemotherapy regimens in the metastatic setting for the dose expansion phase. For the dose escalation cohort, up to three previous lines of chemotherapy in the metastatic setting is acceptable.
- Measurable disease, i.e., at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria only *for expansion cohorts.
- For *escalation cohorts, bone only disease is allowed. For expansion cohorts, there must be measurable disease as stated above.
Key exclusion criteria (22 listed)
- Potential participants with inflammatory breast cancer.
- Prior CDK 4/6 inhibitor exposure.
- Have received Tamoxifen in the metastatic setting (for more than 30 days) or has progressed while on Tamoxifen in the adjuvant setting.
- Known hypersensitivity to ribociclib or excipients of tamoxifen.
- A concurrent malignancy or malignancy within 3 years of starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamoxifenTamoxifen will be taken orally once daily on a continuous daily schedule (e.g., days 1-28 of each 28 day cycle). | Drug | Tamoxifen and Ribociclib with Goserelin |
| RibociclibAlso: LEE011, Cyclin-Dependent Kinase (CDK) InhibitorRibociclib (LEE011) will be taken orally once daily on days 1-21 of each 28 day cycle. Days 22-28 will be a "rest" period from dosing with Ribociclib. In the continuous cohort, 400 mg ribociclib will be given daily (QD). | Drug | Tamoxifen and Ribociclib with Goserelin |
| GoserelinAlso: Zoladex, Goserelin acetateGoserelin will be given as an injectable subcutaneous implant on day 1 of every 28 day cycle. This will be given in pre-menopausal and peri-menopausal women. | Drug | Tamoxifen and Ribociclib with Goserelin |
Primary outcome
Recommended Phase II Dose (RP2D)
Time frame: Up to 12 months
400-600 mg of Ribociclib, when taken with Tamoxifen 20 mg. The Phase I portion of the study is a dose escalation to confirm the dose limiting toxicity (DLT) and the RP2D for ribociclib with Tamoxifen. DLT is defined as an adverse event or abnormal laboratory value assessed as having a reasonable possibility related to the study medication, unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) with LEE011 and Tamoxifen. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading. In this study, a DLT will occur if CTCAE grade 4 neutropenia lasts more than 4 consecutive days, if CTCAE grade 3 thrombocytopenia is associated with clinically significant bleeding or if there is grade 4 thrombocytopenia.
2 secondary outcomes
Progression-free Survival (PFS) at Six Months
Time frame: 6 months
Overall Survival (OS) at Six Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roohi Ismail-Khan, MD, MSc principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tamoxifen, Ribociclib and Goserelin in people with Breast Cancer and Breast Cancer - Female, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose (RP2D) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.