Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

ConditionsBreast Cancer Radiotherapy; Complications Effect of Radiation Therapy

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18-75

SponsorFudan University

About this trial

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG 0-1

Newly diagnosed invasive breast cancer

Initial clincial diagonosis stage is T1-4, N0-3a/b, M0: If neoadjuvant chemotherapy was not administered: pathological stage is T1-3N2-3a/b, M0; If neoadjuvant chemotherapy was administered：clinical stage III or pathological stage is T1-4N1-3a/bM0.

Underwent breast conservative surgery or Mastectomy with or without breast reconstruction with clear negative margin. At least, axillary level I and level II should be cleared with ≥10 lymph node (including the number of sentinal lymph node) . Level III dissection and internal mamamry node dissection are not required, but may be performed at the discretion of the surgeon.

Disqualifiers

Initinal clinical diagnosis N3c (supraclavicualr node metastasis)

T4 or inflamed breast cancer with no good downstage by neoadjuvant chemotherapy

Distant metastasis

Bilateral breast cancer or previously contralateral breast cancer

Trial design

Design model

Parallel

Treatments tested in this trial

Entire supraclavicular lymph node radiotherapy
Radiation
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node. Entire supraclavicular lymph node includes medial supraclavicular and posterior neck lymph node.
Medial supraclavicular lymph node radiotherapy
Radiation
Radiation is delivered to the breast/chest wall, undissected axilla, internal mammary nodes and entire supraclavicular lymph node.

Treatment groups

1,650 Participants

are divided into 2 treatment groups

Group A: Breast/chest wall+undisseted axillary+IMN+medial SCL ( medial SCL radiation)Active comparator 1 intervention

Group B: Breast/chest wall+undisseted axillary+IMN+entie SCL (entire SCL radiation)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Disease free survival (DFS )

defined as time from randomization until to local, regional, or distant recurrence, or any death, or secondary primary cancer

Time frame