A Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

Locally advanced or recurrent metastatic breast cancer, pathologically confirmed;

At least one extracranial measurable lesion suitable for radiotherapy;

Signature of informed consent form.

Disqualifiers

Pregnant or lactation women;

Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radical dose radiotherapy

    Radiation

    Radical dose is delivered for the patients. SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by external beam radiation therapy (EBRT) with EQD2≥60Gy.

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Time frame
3 months

Secondary outcomes

1

Overall Response Rate (ORR)

Time frame
1 month
2

Local control

Time frame
1 year
3

Progression-Free Survival (PFS)

Time frame
1 year
4

Overall Survival (OS)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: