Breast CancerNCT05901025
Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients
An observational study of Breast Cancer, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
The goal of this clinical trial is to learn about the mutation spectrum of homologous recombination repair pathway genes and its instructive significance in the treatment of Chinese breast cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2023to 30 Jun 2033
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Breast cancer patients
Who may be able to join
- Pathology-confirmed breast cancer patients who meet at least one of the criteria below:
- Triple-negative breast cancer
- Age ≤ 50 years
- Male breast cancer
- With personal or family history of malignancy: breast cancer, ovarian cancer, prostate cancer, pancreatic cancer, other malignancies
- HER-2 negative recurrent or metastatic breast cancer
Show all 10Show fewer
- HER-2 negative high-risk breast cancer:
- A: Neoadjuvant phase: non-pathological complete response for triple-negative breast cancer; non-pathological complete response AND CPS+EG score ≥ 3 for hormone receptor positive breast cancer B: Adjuvant phase: ≥ pT2 or ≥ pN1 for triple-negative breast cancer; ≥ 4 lymph node metastasis for hormone receptor positive breast cancer
- Having been or intended to be tested for germline and (or) somatic homologous recombination repair gene mutations
- Consent to providing medical charts and homologous recombination repair gene testing results, and being cooperative for long-term follow-up
Who cannot join
- Homologous recombination repair gene testing results unavailable
- Other factors deemed by the investigators that may sabotage the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients: A Multi-center, Prospective, Observational Study
The goal of this clinical trial is to learn about the mutation spectrum of homologous recombination repair pathway genes and its instructive significance in the treatment of Chinese breast cancer patients.
Read the detailed description
The main questions it aims to answer are:
- What is the mutation spectrum of homologous recombination repair pathway genes in Chinese breast cancer patients?
- Does homologous recombination repair pathway gene mutation have an impact on patient outcome (breast cancer recurrence, neoadjuvant chemotherapy efficacy, treatment decisions, etc.) ? There is no intervention on participants, but all participants will be given regular follow-up post surgery according to ASCO guidelines.
- Conditions
- Breast Cancer
- Keywords
- Homologous Recombination Repair Pathway, Outcome, Mutation
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Homologous recombination repair pathway gene mutation spectrum
to reveal the homologous recombination repair pathway gene mutation spectrum
Measured: At recruitment
Secondary outcomes (2)
Breast cancer events
to compare the incidence of breast cancer-related events and deaths between patients with or without homologous recombination repair pathway gene mutation(s)
Measured: At 5 years from surgery
Treatment decision and appliance
to compare the treatment decision and appliance between patients with or without homologous recombination repair pathway gene mutation(s)
Measured: At 5 years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start5 Jun 2023 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901025
- Sponsor's protocol ID
- RJBC-HRR
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pierce LJ, Levin AM, Rebbeck TR, Ben-David MA, Friedman E, Solin LJ, Harris EE, Gaffney DK, Haffty BG, Dawson LA, Narod SA, Olivotto IA, Eisen A, Whelan TJ, Olopade OI, Isaacs C, Merajver SD, Wong JS, Garber JE, Weber BL. Ten-year multi-institutional results of breast-conserving surgery and radiotherapy in BRCA1/2-associated stage I/II breast cancer. J Clin Oncol. 2006 Jun 1;24(16):2437-43. doi: 10.1200/JCO.2005.02.7888. Epub 2006 Apr 24.
PubMed 16636335Cao W, Xie Y, He Y, Li J, Wang T, Fan Z, Fan T, Ouyang T. Risk of ipsilateral breast tumor recurrence in primary invasive breast cancer following breast-conserving surgery with BRCA1 and BRCA2 mutation in China. Breast Cancer Res Treat. 2019 Jun;175(3):749-754. doi: 10.1007/s10549-019-05199-8. Epub 2019 Mar 20.
PubMed 30895535Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.
PubMed 34081848Tung NM, Robson ME, Ventz S, Santa-Maria CA, Nanda R, Marcom PK, Shah PD, Ballinger TJ, Yang ES, Vinayak S, Melisko M, Brufsky A, DeMeo M, Jenkins C, Domchek S, D'Andrea A, Lin NU, Hughes ME, Carey LA, Wagle N, Wulf GM, Krop IE, Wolff AC, Winer EP, Garber JE. TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes. J Clin Oncol. 2020 Dec 20;38(36):4274-4282. doi: 10.1200/JCO.20.02151. Epub 2020 Oct 29.
PubMed 33119476Telli ML, Jensen KC, Vinayak S, Kurian AW, Lipson JA, Flaherty PJ, Timms K, Abkevich V, Schackmann EA, Wapnir IL, Carlson RW, Chang PJ, Sparano JA, Head B, Goldstein LJ, Haley B, Dakhil SR, Reid JE, Hartman AR, Manola J, Ford JM. Phase II Study of Gemcitabine, Carboplatin, and Iniparib As Neoadjuvant Therapy for Triple-Negative and BRCA1/2 Mutation-Associated Breast Cancer With Assessment of a Tumor-Based Measure of Genomic Instability: PrECOG 0105. J Clin Oncol. 2015 Jun 10;33(17):1895-901. doi: 10.1200/JCO.2014.57.0085. Epub 2015 Apr 6.
PubMed 25847929Silver DP, Richardson AL, Eklund AC, Wang ZC, Szallasi Z, Li Q, Juul N, Leong CO, Calogrias D, Buraimoh A, Fatima A, Gelman RS, Ryan PD, Tung NM, De Nicolo A, Ganesan S, Miron A, Colin C, Sgroi DC, Ellisen LW, Winer EP, Garber JE. Efficacy of neoadjuvant Cisplatin in triple-negative breast cancer. J Clin Oncol. 2010 Mar 1;28(7):1145-53. doi: 10.1200/JCO.2009.22.4725. Epub 2010 Jan 25.
PubMed 20100965Isakoff SJ, Mayer EL, He L, Traina TA, Carey LA, Krag KJ, Rugo HS, Liu MC, Stearns V, Come SE, Timms KM, Hartman AR, Borger DR, Finkelstein DM, Garber JE, Ryan PD, Winer EP, Goss PE, Ellisen LW. TBCRC009: A Multicenter Phase II Clinical Trial of Platinum Monotherapy With Biomarker Assessment in Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2015 Jun 10;33(17):1902-9. doi: 10.1200/JCO.2014.57.6660. Epub 2015 Apr 6.
PubMed 25847936Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. doi: 10.1038/s41591-018-0009-7. Epub 2018 Apr 30.
PubMed 29713086Yu KD, Ye FG, He M, Fan L, Ma D, Mo M, Wu J, Liu GY, Di GH, Zeng XH, He PQ, Wu KJ, Hou YF, Wang J, Wang C, Zhuang ZG, Song CG, Lin XY, Toss A, Ricci F, Shen ZZ, Shao ZM. Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1390-1396. doi: 10.1001/jamaoncol.2020.2965.
PubMed 32789480
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homologous Recombination Repair Pathway Gene Mutation Spectrum in Chinese Breast Cancer Patients: A Multi-center, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05901025
- Acronym / sponsor ID
- RJBC-HRR
- Conditions
- Breast Cancer
- Keywords
- Homologous Recombination Repair Pathway, Outcome, Mutation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 5 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about the mutation spectrum of homologous recombination repair pathway genes and its instructive significance in the treatment of Chinese breast cancer patients.
Detailed description
The main questions it aims to answer are:
- What is the mutation spectrum of homologous recombination repair pathway genes in Chinese breast cancer patients?
- Does homologous recombination repair pathway gene mutation have an impact on patient outcome (breast cancer recurrence, neoadjuvant chemotherapy efficacy, treatment decisions, etc.) ? There is no intervention on participants, but all participants will be given regular follow-up post surgery according to ASCO guidelines.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Breast cancer patients
Key inclusion criteria (10 listed)
- Pathology-confirmed breast cancer patients who meet at least one of the criteria below:
- A: Neoadjuvant phase: non-pathological complete response for triple-negative breast cancer; non-pathological complete response AND CPS+EG score ≥ 3 for hormone receptor positive breast cancer B: Adjuvant phase: ≥ pT2 or ≥ pN1 for triple-negative breast cancer; ≥ 4 lymph node metastasis for hormone receptor positive breast cancer
- Having been or intended to be tested for germline and (or) somatic homologous recombination repair gene mutations
- Consent to providing medical charts and homologous recombination repair gene testing results, and being cooperative for long-term follow-up
Key exclusion criteria (2 listed)
- Homologous recombination repair gene testing results unavailable
- Other factors deemed by the investigators that may sabotage the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Homologous recombination repair pathway gene mutation spectrum
Time frame: At recruitment
to reveal the homologous recombination repair pathway gene mutation spectrum
2 secondary outcomes
Breast cancer events
Time frame: At 5 years from surgery
Treatment decision and appliance
Time frame: At 5 years from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 16636335Pierce LJ, Levin AM, Rebbeck TR, Ben-David MA, Friedman E, Solin LJ, Harris EE, Gaffney DK, Haffty BG, Dawson LA, Narod SA, Olivotto IA, Eisen A, Whelan TJ, Olopade OI, Isaacs C, Merajver SD, Wong JS, Garber JE, Weber BL. Ten-year multi-institutional results of breast-conserving surgery and radiotherapy in BRCA1/2-associated stage I/II breast cancer. J Clin Oncol. 2006 Jun 1;24(16):2437-43. doi: 10.1200/JCO.2005.02.7888. Epub 2006 Apr 24.
- Background: PubMed 30895535Cao W, Xie Y, He Y, Li J, Wang T, Fan Z, Fan T, Ouyang T. Risk of ipsilateral breast tumor recurrence in primary invasive breast cancer following breast-conserving surgery with BRCA1 and BRCA2 mutation in China. Breast Cancer Res Treat. 2019 Jun;175(3):749-754. doi: 10.1007/s10549-019-05199-8. Epub 2019 Mar 20.
- Background: PubMed 34081848Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.
- Background: PubMed 33119476Tung NM, Robson ME, Ventz S, Santa-Maria CA, Nanda R, Marcom PK, Shah PD, Ballinger TJ, Yang ES, Vinayak S, Melisko M, Brufsky A, DeMeo M, Jenkins C, Domchek S, D'Andrea A, Lin NU, Hughes ME, Carey LA, Wagle N, Wulf GM, Krop IE, Wolff AC, Winer EP, Garber JE. TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes. J Clin Oncol. 2020 Dec 20;38(36):4274-4282. doi: 10.1200/JCO.20.02151. Epub 2020 Oct 29.
- Background: PubMed 25847929Telli ML, Jensen KC, Vinayak S, Kurian AW, Lipson JA, Flaherty PJ, Timms K, Abkevich V, Schackmann EA, Wapnir IL, Carlson RW, Chang PJ, Sparano JA, Head B, Goldstein LJ, Haley B, Dakhil SR, Reid JE, Hartman AR, Manola J, Ford JM. Phase II Study of Gemcitabine, Carboplatin, and Iniparib As Neoadjuvant Therapy for Triple-Negative and BRCA1/2 Mutation-Associated Breast Cancer With Assessment of a Tumor-Based Measure of Genomic Instability: PrECOG 0105. J Clin Oncol. 2015 Jun 10;33(17):1895-901. doi: 10.1200/JCO.2014.57.0085. Epub 2015 Apr 6.
- Background: PubMed 20100965Silver DP, Richardson AL, Eklund AC, Wang ZC, Szallasi Z, Li Q, Juul N, Leong CO, Calogrias D, Buraimoh A, Fatima A, Gelman RS, Ryan PD, Tung NM, De Nicolo A, Ganesan S, Miron A, Colin C, Sgroi DC, Ellisen LW, Winer EP, Garber JE. Efficacy of neoadjuvant Cisplatin in triple-negative breast cancer. J Clin Oncol. 2010 Mar 1;28(7):1145-53. doi: 10.1200/JCO.2009.22.4725. Epub 2010 Jan 25.
- Background: PubMed 25847936Isakoff SJ, Mayer EL, He L, Traina TA, Carey LA, Krag KJ, Rugo HS, Liu MC, Stearns V, Come SE, Timms KM, Hartman AR, Borger DR, Finkelstein DM, Garber JE, Ryan PD, Winer EP, Goss PE, Ellisen LW. TBCRC009: A Multicenter Phase II Clinical Trial of Platinum Monotherapy With Biomarker Assessment in Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2015 Jun 10;33(17):1902-9. doi: 10.1200/JCO.2014.57.6660. Epub 2015 Apr 6.
- Background: PubMed 29713086Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. doi: 10.1038/s41591-018-0009-7. Epub 2018 Apr 30.
- Background: PubMed 32789480Yu KD, Ye FG, He M, Fan L, Ma D, Mo M, Wu J, Liu GY, Di GH, Zeng XH, He PQ, Wu KJ, Hou YF, Wang J, Wang C, Zhuang ZG, Song CG, Lin XY, Toss A, Ricci F, Shen ZZ, Shao ZM. Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1390-1396. doi: 10.1001/jamaoncol.2020.2965.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Shanghai Jiao Tong University School of Medicine.
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 10 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Yiwei Tong (0086-021-64370045, ash_yiwei@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homologous recombination repair pathway gene mutation spectrum (time frame: At recruitment). 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 NCT05901025, which also lists 9 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 13 Jun 2023.