Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone

NCT02806258 | Terminated Phase 1 DMC

• 1 other identifier: 38RC14.454
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 6

Brief Summary

In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI

Conditions

Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation; Intermediate and High-risk Luminal and Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PCR rates

  Pathological complete response (pCR), defined by the absence of invasive residual primary tumor in the breast and lymph node.The primary objective of this study is to compare pCR rates after Primary Systemic Therapy (PST) plus APBI versus PST alone in patients with luminal and TNG BC prior to BC surgery.

  At the end of chemotherapy: up to 21 weeks

Secondary Outcomes (3)

• PCR 2

  At the end of chemotherapy: up to 21 weeks

• Breast conservation rate

  Intraoperative

• Acute and late toxicities

  At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks

Study Arms (2)

Arm A

ACTIVE COMPARATOR

6-8 cycles of Primary systemic therapy using anthracycline and/or taxane based regimens, according to their physician's preference and center policy

Drug: Chemotherapy

Arm B

EXPERIMENTAL

The patients will receive 3D conformal or other modality (eg IMRT, VMAT) APBI during their PST sequence. APBI will be planned sequentially between the Primary systemic therapy cycles, 2 weeks after the 3rd/6 or the 4th/8 cycle of PST.

Radiation: Accelerated partial breast irradiation; Drug: Chemotherapy

Interventions

Accelerated partial breast irradiation RADIATION

To date, there is no report on external beam APBI associated with CT in the neoadjuvant setting.In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI.

Arm B

Chemotherapy DRUG

minimum of six cycles of PST using anthracycline and/or taxane based regimens

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age
• Histologically confirmed invasive carcinoma of the breast
• Patient who desires breast conservation
• Tumor stage T1N1, T2-3 N0-1
• Operable BC for which an indication for CT is determined, including T1N1 and high risk T2-3 N0-1 tumors.
• Lobular and/or ductal invasive carcinoma
• Confirmation by imaging (standard +/- MRI) of unicentric and unilateral disease
• Luminal B (defined by hormone receptor positive and grade II-III (if available from core biopsy) and Ki67 ≥ 15% or by genomic analysis) and TNG subtypes
• HER2 negative
• No distant metastases
• No contraindication for PST with anthracycline and/or taxane based regimens
• Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator with the aid of written information.

You may not qualify if:

• Patients considered too frail for CT whatever their age.
• Breast cancer clinical grade T4 and /or with major nodal involvement N2 (clinically, US, MRI or PET-CT).
• Lumpectomy is considered to be possible with an anticipated favourable cosmetic outcome considering the tumor size/breast size
• Multicentricity that would not allow BCS as confirmed by breast imaging
• Uni or bilateral inflammatory (T4d) BC
• Metastatic disease
• Other histology types: ciribriform or tubular or mucinous or epideroid carcinomas
• Her2 positive
• No signed consent to participate in the study
• Previous malignancy (except non melanoma skin cancer, thyroid carcinoma, non-invasive cancers outside the breast and patients with previous cancer in remission since more \> 5 years)
• Patients with psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule
• Patients unwilling or unable to comply with the protocol (especially necessity to undergo breast surgery despite clinical complete response)
• Patients who have received any other investigational drugs within 30 days prior to the screening visit
• Pregnancy
• Active connective tissue disease involving the skin

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (6)

CHI Créteil

Créteil, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

AP-HP Henri mondor

Paris, France

Location

CHU Avicenne

Paris, France

Location

H. Hartmann Institute of Radiotherapy and Radiosurgery

Paris, France

Location

Tenon hospital

Paris, France

Location

Related Publications (1)

• To NH, Gabelle-Flandin I, Luong TMH, Loganadane G, Ouidir N, Boukhobza C, Grellier N, Verry C, Thiolat A, Cohen JL, Radosevic-Robin N, Belkacemi Y. Pathologic Response to Neoadjuvant Sequential Chemoradiation Therapy in Locally Advanced Breast Cancer: Preliminary, Translational Results from the French Neo-APBI-01 Trial. Cancers (Basel). 2023 Mar 29;15(7):2030. doi: 10.3390/cancers15072030.

  PMID: 37046691 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Isabelle Gabelle Flandin, Dr

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: June 20, 2016
• Study Start: April 26, 2016
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (6)