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

NCT04852081 | Unknown DMC

• 1 other identifier: 01-2021
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Stage IV

Keywords

HR +, HER2-negative metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Proportion of patients among study population who have with symptomatic visceral metastasis

  12 months

• Proportion of patients among study population who have treatment-emergent Adverse Events

  12 months

• Proportion of premenopausal women among study population

  12 months

• percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment

  12 months

• Proportion of patients among study population who have visceral metastasis

  12 months

Study Arms (1)

patients with HR+, HER2- advanced or metastatic breast cancer

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: Alpelisib

Interventions

Palbociclib DRUG

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

Also known as: Ibrance

patients with HR+, HER2- advanced or metastatic breast cancer

Ribociclib DRUG

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

Also known as: Kisqali

patients with HR+, HER2- advanced or metastatic breast cancer

Abemaciclib DRUG

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

Also known as: VERZENIO

patients with HR+, HER2- advanced or metastatic breast cancer

Letrozole DRUG

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

patients with HR+, HER2- advanced or metastatic breast cancer

Anastrozole DRUG

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

patients with HR+, HER2- advanced or metastatic breast cancer

Tamoxifen DRUG

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

patients with HR+, HER2- advanced or metastatic breast cancer

Fulvestrant DRUG

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.

Also known as: Faslodex

patients with HR+, HER2- advanced or metastatic breast cancer

Exemestane DRUG

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

Also known as: Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.

patients with HR+, HER2- advanced or metastatic breast cancer

Alpelisib DRUG

Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.

Also known as: PIQRAY

patients with HR+, HER2- advanced or metastatic breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; ribociclib; abemaciclib; Letrozole; Anastrozole; Tamoxifen; Fulvestrant; exemestane; Alpelisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sergei Tjulandin

  N.N. Blokhin National Medical Research Center of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Karaseva

CONTACT

+7 (499) 686-02-37; Karaseva@russco.org

Marina Stenina

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 21, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)