A pilot study for early evaluation and estimation of prognosis of patients with advanced and/or relapsed breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET

A pilot study for early evaluation and estimation of prognosis of patients with advanced and/or relapsed breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET - A pilot study for breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037327

Enrollment

Registered

2019-08-01

Start date

2019-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

FES-PET/CT: before and 2-4 months after the beginning of therapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. patients with advanced and/or recurrent breast cancer with ER positive and HER2 negative 2. patients more than 20 years-old at the time of the informed consent. 3. patients planned to be treated with endocrine therapy ( Aromatase inhibitors, Tamoxifen, Fulvestrant, Toremifene ) and/or CDK4/6 inhibitors ( Palbociclib or Abemaciclib ) 4. patients signed the documentation of the informed consent

Exclusion criteria

Exclusion criteria: 1. patients with the serum fasting glucose level is more than 150mg/dL at the day of entry 2. patients who entered to the other clinical trials 28 days before the day of entry

Design outcomes

Primary

Measure	Time frame
the change rate of FDG-SUVmax	—

Secondary

Measure	Time frame
Tumor mass reduction rate, effective rate, disease-free survival period, survival period, treatment success period	—

Countries

Japan

Contacts

Public ContactIchiei Kuji

Saitama Medical University International Medical Center Department of Nuclear Medicine

kuji@saitama-med.ac.jp042-984-4147

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026