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Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

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ClinicalTrials.gov Identifier: NCT04852081
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Blokhin's Russian Cancer Research Center

Brief 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.

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


Condition or disease Intervention/treatment
Breast Cancer Stage IV Drug: Palbociclib Drug: Ribociclib Drug: Abemaciclib Drug: Letrozole Drug: Anastrozole Drug: Tamoxifen Drug: Fulvestrant Drug: Exemestane Drug: Alpelisib

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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
patients with HR+, HER2- advanced or metastatic breast cancer
patients with HR+, HER2- advanced or metastatic breast cancer
Drug: Palbociclib
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
Other Name: Ibrance

Drug: Ribociclib
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
Other Name: Kisqali

Drug: Abemaciclib
Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)
Other Name: VERZENIO

Drug: Letrozole
Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.

Drug: Anastrozole
Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.

Drug: Tamoxifen
Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.

Drug: Fulvestrant
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.
Other Name: Faslodex

Drug: Exemestane
Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.
Other Name: Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.

Drug: Alpelisib
Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.
Other Name: PIQRAY




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Proportion of patients among study population who have with symptomatic visceral metastasis [ Time Frame: 12 months ]
    Proportion of patients among study population who have with symptomatic visceral metastasis

  2. Proportion of patients among study population who have treatment-emergent Adverse Events [ Time Frame: 12 months ]
    Proportion of patients among study population who have treatment-emergent Adverse Events

  3. Proportion of premenopausal women among study population [ Time Frame: 12 months ]
    Proportion of premenopausal women among study population

  4. percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment [ Time Frame: 12 months ]
    percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment

  5. Proportion of patients among study population who have visceral metastasis [ Time Frame: 12 months ]
    Proportion of patients among study population who have visceral metastasis

  6. Evaluation of the outcome per treatment line [ Time Frame: 12 months ]
    To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with histologically or cytologically confirmed luminal (HR positive/HER2 negative) inoperable locally advanced or metastatic breast cancer
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT04852081


Contacts
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Contact: Vera Karaseva +7 (499) 686-02-37 Karaseva@russco.org
Contact: Marina Stenina

Locations
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Russian Federation
N.N. Blokhin National Medical Research Center of Oncology Recruiting
Moscow, Russian Federation, 115478
Contact: Sergei Tjulandin, MD PhD    +74993249874    stjulandin@mail.ru   
Principal Investigator: Sergei Tjulandin, MD PhD         
Sub-Investigator: Marina Stenina, MD PhD         
Sub-Investigator: Ludmila Zhukova, MD PhD         
Sub-Investigator: Daniil 4. Stroyakovsky, PhD         
Sponsors and Collaborators
Blokhin's Russian Cancer Research Center
Investigators
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Principal Investigator: Sergei Tjulandin N.N. Blokhin National Medical Research Center of Oncology
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Responsible Party: Blokhin's Russian Cancer Research Center
ClinicalTrials.gov Identifier: NCT04852081    
Other Study ID Numbers: 01-2021
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blokhin's Russian Cancer Research Center:
HR +, HER2-negative metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Fulvestrant
Palbociclib
Anastrozole
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Estrogen Receptor Antagonists
Protein Kinase Inhibitors