Endocrine treatment with letrozole, with or without local 3D conformal radiotherapy (3DCRT) of metastatic lesions in postmenopausal patients with inoperable, hormone-sensitive, oligometastatic breast cancer: a multicentre, randomised phase II study

ISRCTN	ISRCTN15692114
DOI	https://doi.org/10.1186/ISRCTN15692114
Secondary identifying numbers	KKSH-13

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Christoph Thomssen
Scientific

Martin-Luther-University Halle-Wittenberg
Medical Faculty
Department of Gynecology
Ernst-Grube Str. 40
Halle/Saale
06120
Germany

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	LETROZOL-3DCRT
Study objectives	Local 3D conformal radiotherapy to metastatic sites, in addition to systemic treatment with letrozole, improves progression-free survival in postmenopausal, hormone-receptor positive patients with oligometastatic breast cancer.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Inoperable, hormone-responsive, oligometastatic breast cancer
Intervention	Endocrine treatment with letrozole 2.5 mg po (orally) daily in both study arms, additional local 3DCRT (50 Gy) to metastatic lesions in the experimental arm
Intervention type	Other
Primary outcome measure	Progression-free survival as measured by the one-year progression-free survival rate
Secondary outcome measures	1. Objective tumor response rate 2. Toxicity 3. 1-, 2-, 3-year survival rates 4. Clinical benefit (defined as proportion of patients with stable disease [SD] >24 weeks, complete response [CR] and partial response [PR]) 5. Quality of life, as measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) C30 and BR-23
Overall study start date	01/10/2005
Completion date	01/10/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	80
Key inclusion criteria	1. Postmenopausal women with histologically or cytologically confirmed, oligometastatic breast cancer, defined as: ≤3 metastatic lesions, or primary tumor and ≤2 metastatic lesions not amenable to curative surgery for medical or surgical reasons 2. No prior endocrine therapy for metastatic disease 3. Estrogen receptor and/or progresterone receptor positive status or with both receptors unknown 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (except patients with metastatic lesions confined to the bones who may be included in case or non-measurable but assessable disease) 5. Age >18 years, Eastern Cooperative Oncology Group (ECOG) 0-2 6. Adequate hematological, renal and hepatic function
Key exclusion criteria	1. Central nervous system (CNS) metastasis or other metastasis in anatomic proximity to peripheral nerves precluding the delivery of the planned radiotherapy 2. Patients requiring immediate treatment with chemotherapy due to extensive visceral involvement or marked clinical symptoms 3. Malignant ascites, pericardial or pleural effusions, malignant infiltration of the bone marrow 4. Malabsorption syndrome or other uncontrolled medical conditions
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2010

Martin-Luther-University Halle-Wittenberg

Halle/Saale
06120
Germany

Martin-Luther-University (Germany)
University/education

Universitätsplatz 10
Halle/Saale
06108
Germany

Website	www.verwaltung.uni-halle.de
"ROR"	https://ror.org/05gqaka33

Government

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (grant no. 01ZP0301/G)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan