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Non Small Cell Lung CancerPhase 3BRECNCT00617656

Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

A Phase 3 study testing Cisplatin, Docetaxel, Gemcitabine, Cisplatin and Docetaxel, Cisplatin in people with Non Small Cell Lung Cancer and BRCA1 Mutation, run by Spanish Lung Cancer Group at 44 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Primary objective: · Progression free survival. Secondary objectives: Assess Overall survival of both treatment groups. Assess Tumor response rate using RECIST criteria Assess Toxicity profile of patients enrolled in the study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, BRCA1 Mutation
What is being tested?
Cisplatin, Docetaxel, Gemcitabine, Cisplatin and Docetaxel, Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
382 participants
Where
44 sitesSpain
Study dates
Feb 2008to Apr 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients age 18 years or more.
  • Histologically confirmed diagnosis of non-small-cell lung carcinoma.
  • Only patients with advanced disease defined as stage IV or IIIB with or without pleural effusion will be included. In the event of IIIB disease without pleural effusion those patients, who for some reason (respiratory disease, large radiation volume...) may not be candidates to have chemotherapy and radiotherapy treatment and may only be treated with chemotherapy, will be considered.
  • Tumor specimen available (according to the criterion of the specimen-processing laboratory) for the analysis of RAP80 and BRCA1 expression in mRNA.
  • A measurable lesion, as defined by RECIST criteria.
  • Karnofsky score 80% or more (ECOG < 2).
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  • No previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the patient's initial diagnosis is limited disease and the patient has received adjuvant or neoadjuvant treatment, as long as a minimum of 6 months has passed since the end of the adjuvant and/or neo-adjuvant chemotherapy.
  • Patients with cerebral disease may be included without any time limitations after holocranial irradiation or complementary antiedema treatment, as long as there is correct control of the clinical symptoms arising from the brain disease or is symptomatic.
  • Patients with the following hematologic values:
  • ANC ≥ 1.5 x 109/L Hb ≥ 10 g/dl Platelets ≥ 100 x 109/L
  • Patients with the following biochemical values:
  • Bilirubin ≤ 1.5 mg/dL AST and ALT < 1.5 upper limit of normality Creatinine clearance ≥ 60 ml/min.
  • Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
  • Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological specimens of tumor and blood.
  • Patients must be available for clinical follow-up.

Who cannot join

  • Previous chemotherapy treatment, except the supposition reflected in inclusion criterion 7.
  • Patients diagnosed of another neoplasm, with the exception of cervical carcinoma in situ, treated squamous cell carcinomas or superficial bladder tumors (Ta and TIS), or other malignant tumors that have received curative treatment within the last 5 years before inclusion in the study.
  • Patients with serious active bacterial or fungal infective processes from a clinical vantage point (= grade 2 of NCI-CTC, Version 3).
  • Patients who have received an investigational medicinal product in the 21 days before inclusion in the study.
  • Patients with HIV infection, HCV infection, coronary artery disease or uncontrolled arrhythmia, uncontrolled cerebrovascular disease, or other clinical conditions that, in the judgment of the investigator, contraindicate the patient's participation in the study.
  • Patients who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test performed within 7 days before the onset of treatment.
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  • Substance abuse and clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance.
  • Patients who present any contraindication or suspected allergy to the products under investigation in the study
  • Impossibility to comply with chemotherapy treatment due to cultural or geographic circumstances.
  • Significant weight loss (= 10% of body weight) in the 6 weeks before inclusion in the study.
  • Any condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study.
  • Contraindication for steroid use.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

Spain44 sites

  • H. Juan Canalejo

    A Coruña, 15006

  • H. Santiago de Compostela

    A Coruña, 15706

  • F.H.Alcorcón

    Alcorcón, Madrid, 28922

  • H. Virgen de los Lirios

    Alcoy, Alicante, 03804

  • H. Gral. Alicante

    Alicante, 03010

  • H. Torrecárdenas

    Almería, 04009

  • Hospital Torrecárdenas

    Almería, 04009

  • H. Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Cruces

    Barakaldo, Bizkaia, 48903

  • H. Clinic i Provincial

    Barcelona, 08036

  • H. Universitario Quirón Dexeus

    Barcelona, 08036

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

  • H. Duran i Reynals-ICO

    Barcelona, 08907

  • Hospital del Mar

    Barcelona

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital General Yagüe

    Burgos, 09005

  • Hospital Ernest Lluch

    Calatayud, Zaragoza, 50299

  • H. Provincial de Castellón

    Castelló, 12002

  • Hospital Reina Sofía

    Córdoba, Córdoba, 14004

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • Hospital Virgen de las Nieves

    Granada, 18014

  • Hospital Ciudad de Jaén

    Jaén, 23007

  • H. Severo Ochoa

    Leganés, Madrid, 28911

  • H. de la Princesa

    Madrid, 28006

  • H.U. Puerta de Hierro

    Madrid, 28035

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Gregorio Marañon

    Madrid

  • Hospital Carlos Haya

    Málaga, 29010

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital D'Althaia

    Manresa, Barcelona, 08243

  • Hospital de Mataró

    Mataró, Barcelona, 08304

  • Hospital Morales Messeguer

    Murcia, 30008

  • Hospital Son Dureta/ Ses Espases

    Palma de Mallorca, 07120

  • H. Son Llátzer

    Palma de Mallorca, 07198

  • Clinica Quiron

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Quirón Madrid

    Pozuelo de Alarcón, Madrid, Madrid

  • Hospital nuestra señora de Valme

    Seville, 41014

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • H. Gen. Univ. Valencia

    Valencia

  • Hospital Arnau de Vilanova

    Valencia

  • H. General de Vic

    Vic, 08500

  • Hospital Clínico Lozano Blesa

    Zaragoza, 50009

  • H. Clínico Lozano Blesa

    Zaragoza, 59009

Other trials in Spain

About this study

Official title: Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer

Primary objective:

  • Progression free survival.

Secondary objectives:

  • Assess Overall survival of both treatment groups.
  • Assess Tumor response rate using RECIST criteria
  • Assess Toxicity profile of patients enrolled in the study.
  • Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.
Read the detailed description

Study population:

Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria).

Duration of treatment:

Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator.

Calendar and planned finalization date:

The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.

Being tested
Cisplatin, Docetaxel, Gemcitabine, Cisplatin, Docetaxel, Cisplatin, Docetaxel
Keywords
Lung Cancer, Chemotherapy, Personalized medicine
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cisplatin, DocetaxelDrug

    Also called Platinol, Taxotere

    Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6

  • Gemcitabine, CisplatinDrug

    Also called Gemzar, Platinol

    Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

  • Docetaxel, CisplatinDrug

    Also called Taxotere, Platinol

    Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Study groups in NCT00617656
Study groupRoleWhat they receive
A: ControlActive comparatorDocetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6
Receives: Drug: Cisplatin, Docetaxel
B1: Experimental group B1ExperimentalLow RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Receives: Drug: Gemcitabine, Cisplatin
B2: Experimental group B2ExperimentalIntermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6
Receives: Drug: Docetaxel, Cisplatin
B3: Experimental group B3ExperimentalIntermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Defined as the length of time from the start of treatment to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.

Secondary outcomes (1)

  1. Overall Survival

    Defined as the length of time from the start of the treatment that patients diagnosed with the disease are still alive.

    Measured: From the date of start of the treatment until death or end of follow up, up to 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionApr 2015
  4. Study completionApr 2015

Why it stopped: No safety reasons. Interim analysis shows that the hypothesis superiority of the experimental arm over the control arm- would not be confirmed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00617656
Sponsor's protocol ID
GECP-BREC
Other IDs
2007-004278-20
Acronym
BREC
Status last verified
Jan 2024
First submitted
5 Feb 2008
Last updated
30 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karachaliou N, Bracht JWP, Fernandez Bruno M, Drozdowskyj A, Gimenez Capitan A, Moran T, Carcereny E, Cobo M, Domine M, Chaib I, Ramirez JL, Camps C, Provencio M, Vergnenegre A, Lopez-Vivanco G, Majem M, Massuti B, Rosell R. Association of PALB2 Messenger RNA Expression with Platinum-Docetaxel Efficacy in Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Feb;14(2):304-310. doi: 10.1016/j.jtho.2018.10.168. Epub 2018 Nov 22.

    PubMed 30472259

  • Moran T, Wei J, Cobo M, Qian X, Domine M, Zou Z, Bover I, Wang L, Provencio M, Yu L, Chaib I, You C, Massuti B, Song Y, Vergnenegre A, Lu H, Lopez-Vivanco G, Hu W, Robinet G, Yan J, Insa A, Xu X, Majem M, Chen X, de Las Penas R, Karachaliou N, Sala MA, Wu Q, Isla D, Zhou Y, Baize N, Zhang F, Garde J, Germonpre P, Rauh S, ALHusaini H, Sanchez-Ronco M, Drozdowskyj A, Sanchez JJ, Camps C, Liu B, Rosell R; Spanish Lung Cancer Group, the French Lung Cancer Group and the Comprehensive Cancer Centre of Drum Tower Hospital in Nanjing; Colinet B, De Greve J, Germonpre P, Chen H, Chen X, Du J, Gao Y, Hu J, Hu W, Kong W, Li L, Li R, Li X, Liu B, Liu J, Lu H, Qian X, Ren W, Song Y, Wang L, Wei J, Wen L, Wu Q, Xiao X, Xu X, Yan J, Yang J, Yang M, Yang Y, Yin J, You C, Yu L, Yue X, Zhang F, Zhang J, Zhou Y, Zhu L, Zou Z, Baize N, Bombaron P, Chouaid C, Dansin E, Fournel P, Fraboulet G, Gervais R, Hominal S, Kahlout S, Lecaer H, Lena H, LeTreut J, Locher C, Molinier O, Monnet I, Oliviero G, Robinet G, Schoot R, Thomas P, Vergnenegre A, Berchem G, Rauh S, Al Husaini H, Aparisi F, Arriola E, Ballesteros I, Barneto I, Bernabe R, Blasco A, Bosch-Barrera J, Bover I, Calvo de Juan V, Camps C, Carcereny E, Catot S, Cobo M, De Las Penas R, Domine M, Felip E, Garcia-Campelo MR, Garcia-Giron C, Garcia-Gomez R, Garcia-Sevila R, Garde J, Gasco A, Gil J, Gonzalez-Larriba JL, Hernando-Polo S, Jantus E, Insa A, Isla D, Jimenez B, Lianes P, Lopez-Lopez R, Lopez-Martin A, Lopez-Vivanco G, Macias JA, Majem M, Marti-Ciriquian JL, Massuti B, Montoyo R, Morales-Espinosa D, Moran T, Moreno MA, Pallares C, Parera M, Perez-Carrion R, Porta R, Provencio M, Reguart N, Rosell R, Rosillo F, Sala MA, Sanchez JM, Sullivan I, Terrasa J, Trigo JM, Valdivia J, Vinolas N, Viteri S, Botia-Castillo M, Mate JL, Perez-Cano M, Ramirez JL, Sanchez-Rodriguez B, Taron M, Tierno-Garcia M, Mijangos E, Ocana J, Pereira E, Shao J, Sun X, O'Brate R. Two biomarker-directed randomized trials in European and Chinese patients with nonsmall-cell lung cancer: the BRCA1-RAP80 Expression Customization (BREC) studies. Ann Oncol. 2014 Nov;25(11):2147-2155. doi: 10.1093/annonc/mdu389. Epub 2014 Aug 27.

    PubMed 25164908

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Docetaxel, Gemcitabine, Cisplatin and Docetaxel, Cisplatin in people with Non Small Cell Lung Cancer and BRCA1 Mutation, run by Spanish Lung Cancer Group at 44 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: From the day of start of treatment until first documented progression or death due to any cause,up to 18 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00617656, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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