Breast Cancer Stage IVNCT04852081
Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.
An observational study of Breast Cancer Stage IV, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
A assessment of the efficacy of first-/second-line endocrine therapies ± target therapies and chemotherapy in real-life of in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer has not yet been conducted in Moscow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage IV
- What is being tested?
- Palbociclib, Ribociclib and Abemaciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: patients with histologically or cytologically confirmed luminal (HR positive/HER2 negative) inoperable locally advanced or metastatic breast cancer
Who may be able to join
- 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 by local laboratory testing and based on the most recently analyzed tissue sample.
- Patient has inoperable locally advanced or metastatic breast cancer
- Patient has adequate bone marrow and organ function
- Patient must be physically well enough that they are capable of treatment
Who cannot join
- Patient has severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may interfere with the interpretation of study results
- no clinical and anamnestic information or information about safety or information about effectiveness treatment
Trial locations and contacts
1 site in 1 country.
Marina Stenina contact
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478
Sergei Tjulandin, MD PhD, +74993249874, stjulandin@mail.ru
Sergei Tjulandin, MD PhD
About this study
Official title: Analysis of Therapy Sequence in Women With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer in Russia: A Multicentre Retrospective Observational Real-life Study.
A assessment of the efficacy of first-/second-line endocrine therapies ± target therapies and chemotherapy in real-life of in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer has not yet been conducted in Moscow.
Methods: Observational, retrospective study carried out in oncology hospitals in Moscow, in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer. The descriptive analysis will be conducted for patient characteristics, responses to treatment and treatment outcomes.
This study will provide retrospective chart review of evidence on the use of therapy in routine clinical practice, with a focus in population of Moscow
Read the detailed description
The combination CDK4/6 inhibitors (CDK4/6i) (Palbociclib, Ribociclib and Abemaciclib) with endocrine therapy (ET, i.e. aro- matase inhibitors (AI) or Fulvestrant) has significantly increased objective response rate (ORR) and progression-free survival (PFS) of first- and second-line treatments in patients with hormone receptor positive, HER2 negative (luminal) mBC. Now this combination is the standard treatment for luminal mBC. Recommendation for endocrine therapy versus chemotherapy as first-line treatment of luminal mBC is endorsed by the main international guidelines such as ASCO and ESO-ESMO guidelines. Endocrine therapy should be used as initial treatment except in cases of immediately life-threatening disease, tumors refractory to endocrine therapy, visceral crisis, or rapid progressive disease that mandate a high response rate treatment. The aim of this study is to provide real-life treatment patterns data for luminal MBC with a focus in population of Moscow
- Conditions
- Breast Cancer Stage IV
- Being tested
- Palbociclib, Ribociclib, Abemaciclib, Letrozole, Anastrozole
- Keywords
- HR +, HER2-negative metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
Palbociclib is in the form of oral capsules. Palbociclib, capsule, 125 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food
RibociclibDrug
Also called Kisqali
Ribociclib, tablets, 600mg orally (three 200 mg tablets)taken once daily with or without food for 21 consecutive days followed by 7 days off treatment
AbemaciclibDrug
Also called VERZENIO
Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)
LetrozoleDrug
Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.
AnastrozoleDrug
Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.
TamoxifenDrug
Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.
FulvestrantDrug
Also called Faslodex
Fulvestrant is in the form of a prefilled syringe containing 5 ml of an injection solution of 250 mg of fulvestrant for intramuscular injection. The recommended dose is once every 28 days, once at a dose of 500 mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500 mg is added.
ExemestaneDrug
Also called Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.
Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.
AlpelisibDrug
Also called PIQRAY
Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| patients with HR+, HER2- advanced or metastatic breast cancer | patients with HR+, HER2- advanced or metastatic breast cancer Receives: Drug: Palbociclib; Drug: Ribociclib; Drug: Abemaciclib; Drug: Letrozole; Drug: Anastrozole; Drug: Tamoxifen; Drug: Fulvestrant; Drug: Exemestane; Drug: Alpelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow
The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
Measured: 12 months
Secondary outcomes (6)
Proportion of patients among study population who have with symptomatic visceral metastasis
Proportion of patients among study population who have with symptomatic visceral metastasis
Measured: 12 months
Proportion of patients among study population who have treatment-emergent Adverse Events
Proportion of patients among study population who have treatment-emergent Adverse Events
Measured: 12 months
Proportion of premenopausal women among study population
Proportion of premenopausal women among study population
Measured: 12 months
percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment
percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment
Measured: 12 months
Proportion of patients among study population who have visceral metastasis
Proportion of patients among study population who have visceral metastasis
Measured: 12 months
Evaluation of the outcome per treatment line
To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergei Tjulandin, Principal investigator, N.N. Blokhin National Medical Research Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852081
- Sponsor's protocol ID
- 01-2021
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Therapy Sequence in Women With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer in Russia: A Multicentre Retrospective Observational Real-life Study.
- ClinicalTrials.gov ID
- NCT04852081
- Acronym / sponsor ID
- 01-2021
- Conditions
- Breast Cancer Stage IV
- Keywords
- HR +, HER2-negative metastatic breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A assessment of the efficacy of first-/second-line endocrine therapies ± target therapies and chemotherapy in real-life of in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer has not yet been conducted in Moscow.
Methods: Observational, retrospective study carried out in oncology hospitals in Moscow, in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer. The descriptive analysis will be conducted for patient characteristics, responses to treatment and treatment outcomes.
This study will provide retrospective chart review of evidence on the use of therapy in routine clinical practice, with a focus in population of Moscow
Detailed description
The combination CDK4/6 inhibitors (CDK4/6i) (Palbociclib, Ribociclib and Abemaciclib) with endocrine therapy (ET, i.e. aro- matase inhibitors (AI) or Fulvestrant) has significantly increased objective response rate (ORR) and progression-free survival (PFS) of first- and second-line treatments in patients with hormone receptor positive, HER2 negative (luminal) mBC. Now this combination is the standard treatment for luminal mBC. Recommendation for endocrine therapy versus chemotherapy as first-line treatment of luminal mBC is endorsed by the main international guidelines such as ASCO and ESO-ESMO guidelines. Endocrine therapy should be used as initial treatment except in cases of immediately life-threatening disease, tumors refractory to endocrine therapy, visceral crisis, or rapid progressive disease that mandate a high response rate treatment. The aim of this study is to provide real-life treatment patterns data for luminal MBC with a focus in population of Moscow
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with HR+, HER2- advanced or metastatic breast cancer | – | Drug: Palbociclib, Drug: Ribociclib, Drug: Abemaciclib, Drug: Letrozole, Drug: Anastrozole, Drug: Tamoxifen, Drug: Fulvestrant, Drug: Exemestane, Drug: Alpelisibpatients with HR+, HER2- advanced or metastatic breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with histologically or cytologically confirmed luminal (HR positive/HER2 negative) inoperable locally advanced or metastatic breast cancer
Key inclusion criteria (5 listed)
- 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 by local laboratory testing and based on the most recently analyzed tissue sample.
- Patient has inoperable locally advanced or metastatic breast cancer
- Patient has adequate bone marrow and organ function
- Patient must be physically well enough that they are capable of treatment
Key exclusion criteria (2 listed)
- Patient has severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may interfere with the interpretation of study results
- no clinical and anamnestic information or information about safety or information about effectiveness treatment
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 |
|---|---|---|
| PalbociclibAlso: IbrancePalbociclib is in the form of oral capsules. Palbociclib, capsule, 125 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| RibociclibAlso: KisqaliRibociclib, tablets, 600mg orally (three 200 mg tablets)taken once daily with or without food for 21 consecutive days followed by 7 days off treatment | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| AbemaciclibAlso: VERZENIOAbemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1) | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| LetrozoleLetrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study. | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| AnastrozoleAnastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study. | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| TamoxifenTamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study. | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| FulvestrantAlso: FaslodexFulvestrant is in the form of a prefilled syringe containing 5 ml of an injection solution of 250 mg of fulvestrant for intramuscular injection. The recommended dose is once every 28 days, once at a dose of 500 mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500 mg is added. | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| ExemestaneAlso: Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study. | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
| AlpelisibAlso: PIQRAYAlpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study. | Drug | patients with HR+, HER2- advanced or metastatic breast cancer |
Primary outcome
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow
Time frame: 12 months
The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
6 secondary outcomes
Proportion of patients among study population who have with symptomatic visceral metastasis
Time frame: 12 months
Proportion of patients among study population who have treatment-emergent Adverse Events
Time frame: 12 months
Proportion of premenopausal women among study population
Time frame: 12 months
percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment
Time frame: 12 months
Proportion of patients among study population who have visceral metastasis
Time frame: 12 months
Evaluation of the outcome per treatment line
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Marina Stenina contact
Sergei Tjulandin principal investigator
N.N. Blokhin National Medical Research Center of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Stage IV, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. 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 Russia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vera Karaseva (+7 (499) 686-02-37, Karaseva@russco.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow (time frame: 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 Apr 2021.