Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower)

NCT05577923 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FUSCC-T-sunflower
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, phase II clinical study for patients with ER+/HER2+ advanced breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  time to progressive disease (according to RECIST1.1)

  Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)

Secondary Outcomes (3)

• ORR

  Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)

• CBR

  Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)

• DOR

  Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 5 years)

Study Arms (1)

T-sunflower group

EXPERIMENTAL

Patients will be treated with Trastuzumab, Pyrotinib, Dalpiciclib plus Fulvestrant.

Drug: Trastuzumab; Drug: pyrotinib; Drug: Dalpiciclib; Drug: fulvestrant

Interventions

Trastuzumab DRUG

8 mg/kg loading dose IV, then 6 mg/kg IV, every 3 weeks

T-sunflower group

pyrotinib DRUG

Pyrotinib 320mg, PO daily, continuously

T-sunflower group

Dalpiciclib DRUG

Dalpiciclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks

T-sunflower group

fulvestrant DRUG

Fulvestrant will be given intramuscle at the dose of 500 mg every 4 weeks (with an additional 500 mg dose given two weeks after the initial dose.

T-sunflower group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ≥18 years and ≤ 75 years old;
• Histologically confirmed ER + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER\> 10% tumor cell positive is defined as ER positive, HER2 3+ or HER2 amplification followed by FISH detection);
• Stage IV breast cancer or recurrent metastatic breast cancer;
• Patients had received no previous chemotherapy or targeted therapy for metastatic disease
• At least one lesion (measurable and/or non-measurable) that has not previously received radiation therapy
• Normal heart function, normal ECG and LVEF ≥ 55%;
• Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL;
• Has adequate liver function and kidney function: TBIL ≤1.5 times of the normal upper limit；ALT and AST ≤3 times of the normal upper limit；if liver metastases，then ALT and AST≤ 5 times of the normal upper limit；serum creatinine ≤1.5 times of the normal upper limit; Child-Pugh A/B（≤9 score）
• Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

You may not qualify if:

• Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
• CNS metastases
• Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
• is pregnant or breast feeding;
• Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
• Positive test for human immunodeficiency virus
• Active hepatitis B or hepatitis C
• Rapid progression of the disease, researchers judge that endocrine combination targeted therapy is not suitable, including the number of liver metastases exceeding 10 or the maximum diameter of a single liver metastases ≥ 10 cm, symptomatic thoraco-ascites, etc.;
• Subjects with uncontrolled lung disease, severe infection, active gastrointestinal ulcer, coagulopathy, severe uncontrolled diabetes, connective tissue disease or inhibition of bone marrow function who cannot tolerate therapy;
• Current use or anticipated need for food or drugs that are known strong CYP3A4 (cytochrome P450 3A4) inhibitors or inducers.
• Strong CYP3A inhibitors, including, boceprevir, clarithromycin, conivaptan, delavirdine, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, suboxone, telaprevir, telithromycin, voriconazole, and grapefruit, grapefruit juice or any product containing grapefruit.
• Strong CYP3A inducers, including carbamazepine, phenytoin, primidone, rifampin, rifapentin, and St. John's wort.
• Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever of unknown origin occurs during the screening period/before the first administration.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; pyrotinib; dalpiciclib; Fulvestrant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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

• zhimin U Shao, professor

  Fudan University Shanghai Cancer Center Shanghai, China, 200032

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhimin U Shao, professor

CONTACT

08602164175590; zhimingshao@yahoo.com

Zhonghua U Wang, professor

CONTACT

08602164175590; zhonghuawang95@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Depending on the DFI, the subjects will be divided into four groups, namely T0, TS(≤2 years), TM(2-5 years), and TL(≥5 years). All subjects will receive the same treatment regimen.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: October 13, 2022
• Study Start: November 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2026
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)