AzTrials
AzTrials

Breast Cancer FemaleBRAVANCT06087120

Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

An observational study of Breast Cancer Female and Stage II Breast Cancer, run by Gene Solutions at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment. Read more about this study

Who is it for?
Ages 18 years and older, women only
How many people
125 participants
Where
3 sitesin 2 countries
Study dates
16 Sep 2023to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include female, from 18 years old or above, who are diagnosed with stage II-III HER2+/Triple Negative breast cancer and indicated for neoadjuvant chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study at University Medical Center HCMC, MRCCC Siloam Hospitals Semanggi (Indonesia).

Who may be able to join

  • Female,18 years old and older,
  • Are diagnosed with stage II-III HER2+/Triple Negative breast cancer and indicated for neoadjuvant chemotherapy,
  • FFPE sample is available at the time of diagnosis and operation,
  • Are voluntary to participate in the study.

Who cannot join

  • Recurrent breast cancer,
  • Other cancer metastasis to the breast,
  • Have been or are being treated for cancer,
  • Patients did not agree to participate in the studies.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Lan NL Tu, PHD contact

+84888843489

lantu@genesolutions.vn

Van T. Phan, MSc contact

+84908145990

vanphan@genesolutions.vn

3 sites in 2 countries

Vietnam2 sites, 2 recruiting

  • Medical Genetics Institute

    Ho Chi Minh City

    Lan NL Tu, PhD, +84888843489, lantu@genesolutions.vn

    Sinh D. Nguyen, PhD. MD

    Recruiting

  • University Medical Center HCMC

    Ho Chi Minh City

    Trung Q Lam, MD

    Trung Q Lam, MD

    Recruiting

Other trials in Vietnam

Indonesia1 site, 1 recruiting

  • MRCCC Siloam Hospitals Semanggi

    Jakarta

    Samuel J Haryono, MD, (+62) 021 56967525, samuelharyono@dharmaissurgonc.com

    Recruiting

Other trials in Indonesia

About this study

Official title: Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.

This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment.

  • Determine the rate of ctDNA positivity at the time before treatment,
  • Determine the rate of ctDNA positivity at the time during treatment,
  • Determine the rate of ctDNA positivity at the time after neoadjuvant therapy, whether there is a change in ctDNA expression of the study population during treatment.
Read more

And aiming to investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy:

  • Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,
  • Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI
  • Combination of ctDNA detection and MRI imaging in the prognosis of pCR. Determination of PPV, NPV ratio of ctDNA combined with MRI.
Read the detailed description

This is a prospective and observational study recruiting Female participants aged 18 and older, who are diagnosed with stage II-III HER+/Triple Negative Breast cancer and indicated for neoadjuvant chemotherapy at University Medical Center HCMC, had FFPE sample at the time of diagnosis and operation. This study is conducted at the Medical Genetics Institute (MGI), and MRCCC Siloam Hospitals Semanggi (Indonesia) in collaboration with the University Medical Center HCMC.

Eligible neoadjuvant chemotherapy (NAC) / treatment regimen for the study:

  • AC-T (Doxorubicin, Cyclophosphamid - Taxane).
  • AC-TH (Doxorubicin, Cyclophosphamid - Taxane - Trastuzumab).
  • TCH (Docetaxel - Carboplatin - Trastuzumab).
  • TCHP (Docetaxel - Carboplatin - Trastuzumab - Pertuzumab).

Patients are allowed to change protocol if required clinically.

The potential and voluntary participants, satisfy all the inclusion/exclusion criteria will be recruited into this study.

At enrollment, each participant will answer to the pre-designed questionnaires of demographic information, medical history.

At routine visits, the participants' clinical information and routine para-clinical results such as breast ultrasound or MRI or CT scan, chest x-ray, mamography, bone or PET-CT scan, CA 15-3 will be collected by Physicians.

Participant in this study will have samples collected the following period of time.

  • At enrollment (Pre-NAC, at diagnosis): 10ml of peripheral blood for ctDNA analysis and 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples collected as biopsy before treatment.
  • During NAC, 10ml of peripheral blood will be collected for ctDNA analysis and Ultrasound scan of neck, breast, abdomen and pelvis; chest x-ray, CA15-3; CT Scan of the neck, abdomen and pelvis (if any) will be also collected.
  • Post-NAC, 10ml of peripheral blood will be collected for ctDNA analysis and Ultrasound scan of neck, breast, abdomen and pelvis; chest x-ray, CA15-3; CT Scan of the neck, abdomen and pelvis, PET-CT scan (if any) will be also collected to compare to treatment respondence between ctDNA and imaging groups.
  • After surgery, 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples collected.

The study end date of a participant is estimated 1 year since enrollment date.

Keywords
Liquid Biopsy, Circulating Tumour DNA, Vietnam, Indonesia
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What is being measured

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

  1. Determine the detection rate and change of ctDNA in blood samples of cancer patients before, during, and after neoadjuvant treatment.

    • Determine the rate of ctDNA positivity at the time before treatment
    • Determine the rate of ctDNA positivity at the time during treatment
    • Determine the rate of ctDNA positivity at the time after neoadjuvant therapy whether there is a change in ctDNA expression of the study population during treatment.

    Measured: 12 months following up.

  2. To investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy.

    • Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,
    • Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI,
    • Combination of ctDNA detection and MRI imaging in the prognosis of pCR, Determination of PPV, NPV ratio of ctDNA combined with MRI.

    Measured: 12 months following up.

Timeline

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

  1. First posted17 Oct 2023
  2. Study start16 Sep 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087120
Sponsor's protocol ID
GS_ZNAB
Acronym
BRAVA
Status last verified
Sep 2025
First submitted
11 Oct 2023
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with suitable study will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be share with any other person/organization than authorized in the study.

Publications

  • Schneeweiss A, Mobus V, Tesch H, Hanusch C, Denkert C, Lubbe K, Huober J, Klare P, Kummel S, Untch M, Kast K, Jackisch C, Thomalla J, Ingold-Heppner B, Blohmer JU, Rezai M, Frank M, Engels K, Rhiem K, Fasching PA, Nekljudova V, von Minckwitz G, Loibl S. Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto-GBG 84): A randomised phase III trial. Eur J Cancer. 2019 Jan;106:181-192. doi: 10.1016/j.ejca.2018.10.015. Epub 2018 Dec 5.

    PubMed 30528802

  • Gianni L, Mansutti M, Anton A, Calvo L, Bisagni G, Bermejo B, Semiglazov V, Thill M, Chacon JI, Chan A, Morales S, Alvarez I, Plazaola A, Zambetti M, Redfern AD, Dittrich C, Dent RA, Magazzu D, De Fato R, Valagussa P, Tusquets I. Comparing Neoadjuvant Nab-paclitaxel vs Paclitaxel Both Followed by Anthracycline Regimens in Women With ERBB2/HER2-Negative Breast Cancer-The Evaluating Treatment With Neoadjuvant Abraxane (ETNA) Trial: A Randomized Phase 3 Clinical Trial. JAMA Oncol. 2018 Mar 1;4(3):302-308. doi: 10.1001/jamaoncol.2017.4612.

    PubMed 29327055

  • Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8.

    PubMed 26869049

  • Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.

    PubMed 29501363

  • Loibl S, Untch M, Burchardi N, Huober J, Sinn BV, Blohmer JU, Grischke EM, Furlanetto J, Tesch H, Hanusch C, Engels K, Rezai M, Jackisch C, Schmitt WD, von Minckwitz G, Thomalla J, Kummel S, Rautenberg B, Fasching PA, Weber K, Rhiem K, Denkert C, Schneeweiss A. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study. Ann Oncol. 2019 Aug 1;30(8):1279-1288. doi: 10.1093/annonc/mdz158.

    PubMed 31095287

  • Gianni L, Huang CS, Egle D, Bermejo B, Zamagni C, Thill M, Anton A, Zambelli S, Bianchini G, Russo S, Ciruelos EM, Greil R, Semiglazov V, Colleoni M, Kelly C, Mariani G, Del Mastro L, Maffeis I, Valagussa P, Viale G. Pathologic complete response (pCR) to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk and locally advanced breast cancer: NeoTRIP Michelangelo randomized study. Ann Oncol. 2022 May;33(5):534-543. doi: 10.1016/j.annonc.2022.02.004. Epub 2022 Feb 17.

    PubMed 35182721

  • Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.

    PubMed 24529560

  • Giannone G, Milani A, Geuna E, Galizia D, Biello F, Montemurro F. What is the best pharmacotherapeutic strategy for HER-2 positive breast cancer? Expert Opin Pharmacother. 2019 Jan;20(1):5-9. doi: 10.1080/14656566.2018.1543406. Epub 2018 Nov 6. No abstract available.

    PubMed 30396301

  • Montemurro F, Nuzzolese I, Ponzone R. Neoadjuvant or adjuvant chemotherapy in early breast cancer? Expert Opin Pharmacother. 2020 Jun;21(9):1071-1082. doi: 10.1080/14656566.2020.1746273. Epub 2020 Apr 1.

    PubMed 32237920

  • Stoetzer OJ, Fersching DM, Salat C, Steinkohl O, Gabka CJ, Hamann U, Braun M, Feller AM, Heinemann V, Siegele B, Nagel D, Holdenrieder S. Circulating immunogenic cell death biomarkers HMGB1 and RAGE in breast cancer patients during neoadjuvant chemotherapy. Tumour Biol. 2013 Feb;34(1):81-90. doi: 10.1007/s13277-012-0513-1. Epub 2012 Sep 15.

    PubMed 22983919

  • Bottini A, Berruti A, Tampellini M, Morrica B, Brunelli A, Gnocchi E, Brizzi MP, Aguggini S, Fara E, Alquati P, Dogliotti L. Influence of neoadjuvant chemotherapy on serum tumor markers CA 15-3, MCA, CEA, TPS and TPA in breast cancer patients with operable disease. Tumour Biol. 1997;18(5):301-10. doi: 10.1159/000218043.

    PubMed 9276030

  • Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

    PubMed 24553385

  • Swarup V, Rajeswari MR. Circulating (cell-free) nucleic acids--a promising, non-invasive tool for early detection of several human diseases. FEBS Lett. 2007 Mar 6;581(5):795-9. doi: 10.1016/j.febslet.2007.01.051. Epub 2007 Feb 2.

    PubMed 17289032

  • Ortolan E, Appierto V, Silvestri M, Miceli R, Veneroni S, Folli S, Pruneri G, Vingiani A, Belfiore A, Cappelletti V, Vismara M, Dell'Angelo F, De Cecco L, Bianchi GV, de Braud FG, Daidone MG, Di Cosimo S. Blood-based genomics of triple-negative breast cancer progression in patients treated with neoadjuvant chemotherapy. ESMO Open. 2021 Apr;6(2):100086. doi: 10.1016/j.esmoop.2021.100086. Epub 2021 Mar 17.

    PubMed 33743331

  • Cavallone L, Aguilar-Mahecha A, Lafleur J, Brousse S, Aldamry M, Roseshter T, Lan C, Alirezaie N, Bareke E, Majewski J, Ferrario C, Hassan S, Discepola F, Seguin C, Mihalcioiu C, Marcus EA, Robidoux A, Roy JA, Pelmus M, Basik M. Prognostic and predictive value of circulating tumor DNA during neoadjuvant chemotherapy for triple negative breast cancer. Sci Rep. 2020 Sep 7;10(1):14704. doi: 10.1038/s41598-020-71236-y.

    PubMed 32895401

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer Female and Stage II Breast Cancer, run by Gene Solutions at 3 sites in 2 countries.

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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Vietnam, Indonesia. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Lan NL Tu, PHD (+84888843489, lantu@genesolutions.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the detection rate and change of ctDNA in blood samples of cancer patients before, during, and after neoadjuvant treatment. (time frame: 12 months following up.). The study lists 2 primary outcomes in all. 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 NCT06087120, which also lists 20 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 23 Sep 2025.

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