Anatomic Stage IV Breast Cancer AJCC v8Phase 2NCT04256941
Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study
A Phase 2 study testing Abemaciclib, Anastrozole and Fulvestrant in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and/or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has spread to other places in the body (metastatic) and has an ERS1 activating mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- What is being tested?
- Abemaciclib, Anastrozole and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 22 Sep 2023
- Phase
- Phase 2
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Platelets >= 50 x 10^9/L
- Hemoglobin (Hb) >= 9 g/dL
- Total serum bilirubin =< 2.0 mg/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN in patients with liver metastases)
Show all 10Show fewer
- Serum creatinine =< 1.5 x ULN
- Activating ESR1 mutation (e.g. D538G, Y537S/N, S463P) identified on ctDNA. Novel ESR1 alterations allowed as per discretion of principal investigator (PI)
- On AI with CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) as first line therapy for metastatic breast cancer (MBC) for at least 12 months without evidence of clinical progression
- Patients with histologically confirmed HR positive (estrogen receptor [ER] positive [+] and/or progesterone receptor [PR]+ [> 10%]), MBC
Who cannot join
- Pregnant or lactating women
- Received prior therapy for MBC (except for AI use for up to 4 weeks prior to initiation of CDK4/6 inhibitor)
- Prior therapy with fulvestrant in the metastatic setting
- Corrected QT (QTc) interval > 480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes
- Psychiatric illness which would limit informed consent
- Patients with de novo metastatic disease
Show all 14Show fewer
- Patients who have any severe and/or uncontrolled medical conditions such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =< 6 months prior to enrollment, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease, active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e. quantifiable hepatitis B virus [HBV]-DNA and/or positive hepatitis B surface antigen [HbsAg], quantifiable hepatitis C virus [HCV]-ribonucleic acid [RNA]), severe hepatic impairment (Child-Pugh C)
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
- Expected survival < 6 months
- Any serious medical illness, other than that treated by this study, which would limit survival to less than 1 month
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
- Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after the end of treatment. Highly effective contraception methods include combination of any two of the following: placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; total abstinence or; male/female sterilization
- Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INTERACT- Integrated Evaluation of Resistance and Actionability Using Circulating Tumor DNA in HR Positive Metastatic Breast Cancers
This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and/or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has spread to other places in the body (metastatic) and has an ERS1 activating mutation. Letrozole, anastrozole, ribociclib, palbociclib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known if giving letrozole, anastrozole, or fulvestrant with ribociclib, palbociclib, and/or abemaciclib will work better in treating patients with breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess progression free survival (PFS) with transition to fulvestrant compared with continuing aromatase inhibitor (AI) therapy in patients with emergence of estrogen receptor 1 (ESR1) mutations in plasma.
SECONDARY OBJECTIVES:
- To assess circulating tumor deoxyribonucleic acid (ctDNA) ESR1 mutant allele fraction (MAF) and kinetics with fulvestrant compared with AI.
II. To assess the prevalence of ESR1 mutations in patients with secondary resistance to endocrine therapy.
III. To correlate ctDNA with cancer antigens (CA) 15-3 tumor marker changes. IV. To assess overall survival (OS) with transition to fulvestrant compared with continuing AI therapy in patients with emergence of ESR1 mutations.
- To assess PFS and time to next treatment (TTNT) on next line of therapy after progression on fulvestrant versus (vs.) AI in combination with CDKI.
EXPLORATORY OBJECTIVES:
- Characterize other co-existing actionable genomic alterations of interest in relation to ESR1 and clinical outcomes.
II. To determine frequency of other actionable genomic alterations and frequency of enrollment on genotype-matched therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ribociclib orally (PO) once daily (QD), palbociclib PO QD on days 1-21, and/or abemaciclib PO twice daily (BID) on days 1-28. Patients also receive fulvestrant intramuscularly (IM) for 2 injections over 1-2 minutes each on days 1 and 15 of cycle 1 and day 2 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ribociclib orally PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive letrozole PO QD or anastrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Being tested
- Abemaciclib, Anastrozole, Fulvestrant, Letrozole, Palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called LY-2835219, LY2835219, Verzenio
Given PO
AnastrozoleDrug
Also called Anastrazole, Arimidex, ICI D1033, ICI-D1033
Given PO
FulvestrantDrug
Also called Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780
Given IM
LetrozoleDrug
Also called CGS 20267, Femara
Given PO
PalbociclibDrug
Also called 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991
Given PO
RibociclibDrug
Also called Kisqali, LEE-011, LEE011
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ribociclib, palbociclib, abemaciclib, fulvestrant) | Experimental | Patients receive ribociclib PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive fulvestrant IM for 2 injections over 1-2 minutes each on days 1 and 15 of cycle 1 and day 2 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Abemaciclib; Drug: Fulvestrant; Drug: Palbociclib; Drug: Ribociclib |
| Arm II (ribociclib, palbociclib, abemaciclib, letrozole) | Active comparator | Patients receive ribociclib orally PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive letrozole PO QD or anastrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Abemaciclib; Drug: Anastrozole; Drug: Letrozole; Drug: Palbociclib; Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Survival curves for PFS will be analyzed using the Kaplan-Meier method and survival difference across groups will be examined by log rank test. Will estimate the treatment comparison with 95% confidence intervals and p-value using Cox proportional hazards regression and we will assess the proportional hazard assumption using graphs of rescaled Schoenfeld residuals and related tests.
Measured: Up to 30 days
Secondary outcomes (5)
Circulating Tumor Deoxyribonucleic Acid (ctDNA) ESR1 Mutant Allele Fraction (MAF) and Kinetics
Graphical analysis, such as scatter plots with Lowess smoothers, will be used to assess the correlative structure of outcomes and compare MAF between fulvestrant and aromatase inhibitor-treated groups. The Pearson correlation, or its non-parametric analogue, the Spearman correlation, will be used to estimate the linear correlation among variables.
Measured: Up to 30 days
Prevalence of Emergence of Estrogen Receptor 1 (ESR1) Mutations
Will be assessed by the secondary resistance of endocrine therapy.
Measured: Up to 30 days
Changes in Cancer Antigens (CA) 15-3 Tumor Marker
Will correlate ctDNA with CA 15-3 tumor marker changes.
Measured: Up to 30 days
Overall Survival (OS)
Survival curves for OS will be analyzed using the Kaplan-Meier method and survival difference across groups will be examined by log rank test. Will estimate the treatment comparison with 95% confidence intervals and p-value using Cox proportional hazards regression and we will assess the proportional hazard assumption using graphs of rescaled Schoenfeld residuals and related tests.
Measured: Up to 30 days
Time to Next Treatment
Will be assessed on next line of therapy after progression.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start31 May 2019
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Why it stopped: Despite modifications, accrual was poor and the closed
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 Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Senthilkumar Damodaran, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256941
- Sponsor's protocol ID
- 2018-0287
- Other IDs
- NCI-2019-08825, 2018-0287
- Status last verified
- Dec 2024
- First submitted
- 21 Jan 2020
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERACT- Integrated Evaluation of Resistance and Actionability Using Circulating Tumor DNA in HR Positive Metastatic Breast Cancers
- ClinicalTrials.gov ID
- NCT04256941
- Acronym / sponsor ID
- 2018-0287
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite modifications, accrual was poor and the closed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well letrozole, anastrozole, or fulvestrant work when given together with ribociclib, palbociclib, and/or abemaciclib in treating patients with hormone receptor (HR) positive breast cancer that has spread to other places in the body (metastatic) and has an ERS1 activating mutation. Letrozole, anastrozole, ribociclib, palbociclib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known if giving letrozole, anastrozole, or fulvestrant with ribociclib, palbociclib, and/or abemaciclib will work better in treating patients with breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- To assess progression free survival (PFS) with transition to fulvestrant compared with continuing aromatase inhibitor (AI) therapy in patients with emergence of estrogen receptor 1 (ESR1) mutations in plasma.
SECONDARY OBJECTIVES:
- To assess circulating tumor deoxyribonucleic acid (ctDNA) ESR1 mutant allele fraction (MAF) and kinetics with fulvestrant compared with AI.
II. To assess the prevalence of ESR1 mutations in patients with secondary resistance to endocrine therapy.
III. To correlate ctDNA with cancer antigens (CA) 15-3 tumor marker changes. IV. To assess overall survival (OS) with transition to fulvestrant compared with continuing AI therapy in patients with emergence of ESR1 mutations.
- To assess PFS and time to next treatment (TTNT) on next line of therapy after progression on fulvestrant versus (vs.) AI in combination with CDKI.
EXPLORATORY OBJECTIVES:
- Characterize other co-existing actionable genomic alterations of interest in relation to ESR1 and clinical outcomes.
II. To determine frequency of other actionable genomic alterations and frequency of enrollment on genotype-matched therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ribociclib orally (PO) once daily (QD), palbociclib PO QD on days 1-21, and/or abemaciclib PO twice daily (BID) on days 1-28. Patients also receive fulvestrant intramuscularly (IM) for 2 injections over 1-2 minutes each on days 1 and 15 of cycle 1 and day 2 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ribociclib orally PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive letrozole PO QD or anastrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ribociclib, palbociclib, abemaciclib, fulvestrant) | Experimental | Drug: Abemaciclib, Drug: Fulvestrant, Drug: Palbociclib, Drug: RibociclibPatients receive ribociclib PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive fulvestrant IM for 2 injections over 1-2 minutes each on days 1 and 15 of cycle 1 and day 2 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm II (ribociclib, palbociclib, abemaciclib, letrozole) | Active comparator | Drug: Abemaciclib, Drug: Anastrozole, Drug: Letrozole, Drug: Palbociclib, Drug: RibociclibPatients receive ribociclib orally PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive letrozole PO QD or anastrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- Platelets >= 50 x 10^9/L
- Hemoglobin (Hb) >= 9 g/dL
- Total serum bilirubin =< 2.0 mg/dL
Key exclusion criteria (14 listed)
- Pregnant or lactating women
- Received prior therapy for MBC (except for AI use for up to 4 weeks prior to initiation of CDK4/6 inhibitor)
- Prior therapy with fulvestrant in the metastatic setting
- Corrected QT (QTc) interval > 480 msec, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes
- Psychiatric illness which would limit informed consent
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 |
|---|---|---|
| AbemaciclibAlso: LY-2835219, LY2835219, VerzenioGiven PO | Drug | Arm I (ribociclib, palbociclib, abemaciclib, fulvestrant), Arm II (ribociclib, palbociclib, abemaciclib, letrozole) |
| AnastrozoleAlso: Anastrazole, Arimidex, ICI D1033, ICI-D1033Given PO | Drug | Arm II (ribociclib, palbociclib, abemaciclib, letrozole) |
| FulvestrantAlso: Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780Given IM | Drug | Arm I (ribociclib, palbociclib, abemaciclib, fulvestrant) |
| LetrozoleAlso: CGS 20267, FemaraGiven PO | Drug | Arm II (ribociclib, palbociclib, abemaciclib, letrozole) |
| PalbociclibAlso: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991Given PO | Drug | Arm I (ribociclib, palbociclib, abemaciclib, fulvestrant), Arm II (ribociclib, palbociclib, abemaciclib, letrozole) |
| RibociclibAlso: Kisqali, LEE-011, LEE011Given PO | Drug | Arm I (ribociclib, palbociclib, abemaciclib, fulvestrant), Arm II (ribociclib, palbociclib, abemaciclib, letrozole) |
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to 30 days
Survival curves for PFS will be analyzed using the Kaplan-Meier method and survival difference across groups will be examined by log rank test. Will estimate the treatment comparison with 95% confidence intervals and p-value using Cox proportional hazards regression and we will assess the proportional hazard assumption using graphs of rescaled Schoenfeld residuals and related tests.
5 secondary outcomes
Circulating Tumor Deoxyribonucleic Acid (ctDNA) ESR1 Mutant Allele Fraction (MAF) and Kinetics
Time frame: Up to 30 days
Prevalence of Emergence of Estrogen Receptor 1 (ESR1) Mutations
Time frame: Up to 30 days
Changes in Cancer Antigens (CA) 15-3 Tumor Marker
Time frame: Up to 30 days
Overall Survival (OS)
Time frame: Up to 30 days
Time to Next Treatment
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink 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.
Senthilkumar Damodaran, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib, Anastrozole and Fulvestrant in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by M.D. Anderson Cancer Center 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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 27 Dec 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Dec 2024). 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?
Progression-free Survival (PFS) (time frame: Up to 30 days). 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 27 Dec 2024.