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

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

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Contact: Marina Stenina

Locations

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

• Principal Investigator: Sergei Tjulandin; N.N. Blokhin National Medical Research Center of Oncology

More Information

• Responsible Party: Blokhin's Russian Cancer Research Center
• ClinicalTrials.gov Identifier: NCT04852081
• Other Study ID Numbers: 01-2021
• First Posted: April 21, 2021
• Last Update Posted: April 21, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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