Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

Study Overview
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Brief Summary
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After neoadjuvant chemotherapy, patients normally receive either conservative breast surgery or mastectomy followed by radiation therapy. Some patients achieve a complete response after neoadjuvant chemotherapy. Considering that radiation therapy is an effective treatment for subclinical microscopic disease, the question arises whether breast surgery before radiation therapy can be avoided in the subgroup of patients with complete response after neoadjuvant chemotherapy.

Official Title
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Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

Conditions
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Breast Cancer, Radiation Therapy

Intervention / Treatment
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* Radiation: Radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 years or older Pathologically confirmed unicentric invasive breast cancer Clinical stage T1-3 / N0 or N2 / M0 Clinical conditions to receive neoadjuvant chemotherapy Exclusion Criteria: Prior diagnosis of cancer (exception: in situ cervical tumor and non-melanoma skin) Patient is known to be pregnant Prior history of radiation therapy in the thoracic region Impossibility to perform magnetic resonance imaging

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT<br>After clinical response, breast magnetic resonance imaging (MRI) is performed and analyzed by two independent radiologists. Complete image response is defined by no enhanced tumor visible on any serial images. Radiation therapy to the breast with or without regional nodal area is performed within 12 weeks after completion of chemotherapy with conventional dose (25x200cGy). Additional boost of 16 Gy in the primary involved tumor region. | Radiation: Radiation therapy<br>* Radiation therapy to the breast with or without regional nodal area is performed within 12 weeks after completion of chemotherapy with conventional dose (25x200cGy). Additional boost of 16 Gy in the primary involved tumor region. Techniques: 3D conformal radiation therapy or intensity modulated radiation therapy (IMRT). Standard systemic treatment for patients with hormonal positive receptor (hormone therapy for at least 5 years) and HER2 positive (trastuzumab for 1 year)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ipsilateral breast tumor recurrence (IBTR) | IBTR is defined from the date from complete response of neoadjuvant chemotherapy to the date of any ipsilateral locoregional recurrence or deth. | 5 years |