Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

Instituto do Cancer do Estado de São Paulo

Status and phase: Enrolling; Phase 2

Conditions: Radiation Therapy; Breast Cancer

Treatments: Radiation: Radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03213925

RT alone

Details and patient eligibility

About

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.

Enrollment: 1 estimated patient

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

RT

Experimental group

Description:

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.

Treatment:

Radiation: Radiation therapy