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Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone (Néo-APBI-01)

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ClinicalTrials.gov Identifier: NCT02806258
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation Intermediate and High-risk Luminal and Triple Negative Breast Cancer Radiation: Accelerated partial breast irradiation Drug: Chemotherapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone, for Triple Negative Locally Advanced Breast Cancers and Luminal B Proliferating, Inaccessible to a Conservative Surgery the Outset
Actual Study Start Date : March 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A
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
minimum of six cycles of PST using anthracycline and/or taxane based regimens

Experimental: Arm B
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
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.

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




Primary Outcome Measures :
  1. PCR rates [ Time Frame: At the end of chemotherapy: up to 21 weeks ]
    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.


Secondary Outcome Measures :
  1. PCR 2 [ Time Frame: At the end of chemotherapy: up to 21 weeks ]
    Breast and axilla pathological complete response rate (pCR2)

  2. Breast conservation rate [ Time Frame: Intraoperative ]
    Breast conservation rate

  3. Acute and late toxicities [ Time Frame: At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks ]
    Acute and late toxicities (CTCAE v 4.0)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806258


Contacts
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Contact: Isabelle Gabelle Flandin, Dr + 33 4.76.76.54.35 IGabelleFlandin@chu-grenoble.fr
Contact: Yazid BELKACEMI, MD, PhD + 33 1.49.81.45.22 yazid.belkacemi@hmn.aphp.fr

Locations
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France
CHU de Grenoble Recruiting
Grenoble Cedex 09, France, 38043
Contact: Christophe Mendoza    +33 4.76.76.94.81    ChMendoza@chu-grenoble.fr   
AP-HP Henri mondor Not yet recruiting
Paris, France
Contact: Yazid BELKACEMI, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02806258     History of Changes
Other Study ID Numbers: 38RC14.454
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases