Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03213925

Enrollment

Registered

2017-07-11

Start date

2017-06-01

Completion date

2025-07-01

Last updated

2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Radiation Therapy

Brief summary

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.

Interventions

RADIATIONRadiation therapy

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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 75 Years

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

Design outcomes

Primary

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

Countries

Brazil

Contacts

Primary ContactGustavo N Marta, PhD

gustavo.marta@hc.fm.usp.br+55 11 38934538

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026