Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer

NCT05872412 | Unknown Phase 2 DMC

• 1 other identifier: BSMMU/2023/6669
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, individuals with triple-negative breast cancer will receive either a platinum-based or non-platinum-based preoperative chemotherapy treatment. This study will help us identify which option is the most effective and safe.

Conditions

Triple Negative Breast Cancer

Keywords

Triple negative breast cancer; Platinum; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  Pathological complete response: Post-operative pathology revealed no residual invasive cancer in the breast or lymph nodes.

  1 year

Secondary Outcomes (2)

• Clinical response

  1 year

• Treatment related acute toxicity

  1 year

Study Arms (2)

Platinum-based regimen

EXPERIMENTAL

Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks concurrently with carboplatin (area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles).

Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Carboplatin

Non-platinum based regimen

ACTIVE COMPARATOR

Patients will be treated with doxorubicin 60 mg/m2 IV on day 1 and cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for four cycles, followed by paclitaxel 80 mg/m2 IV weekly for 12 weeks.

Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel

Interventions

Doxorubicin DRUG

60 mg/m2 IV bolus on day 1 every three weeks for four cycles.

Also known as: Adriamycin

Non-platinum based regimen; Platinum-based regimen

Cyclophosphamide DRUG

600 mg/m2 IV over 1 hour on day 1 every three weeks for four cycles.

Also known as: Cytoxan

Non-platinum based regimen; Platinum-based regimen

Paclitaxel DRUG

80 mg/m2 IV over 1 hour weekly for 12 weeks

Also known as: Taxol

Non-platinum based regimen; Platinum-based regimen

Carboplatin DRUG

Area under the curve: 6 mg/ml/min, i.v. every 3 weeks for four cycles

Also known as: Paraplatin

Platinum-based regimen

Eligibility Criteria

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

You may qualify if:

• Triple-negative breast cancer
• Stage II and III

You may not qualify if:

• Double primaries
• Male breast cancer
• Pregnant or lactating women
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status more than two
• Patients below 18 years old
• Initial surgery of the primary site (excluding diagnostic biopsy)
• Serious concomitant medical illness including clinically significant cardiovascular disease
• Major surgery or trauma in the previous four weeks

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (10)

• von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.

  PMID: 24794243 BACKGROUND

• Zhang P, Yin Y, Mo H, Zhang B, Wang X, Li Q, Yuan P, Wang J, Zheng S, Cai R, Ma F, Fan Y, Xu B. Better pathologic complete response and relapse-free survival after carboplatin plus paclitaxel compared with epirubicin plus paclitaxel as neoadjuvant chemotherapy for locally advanced triple-negative breast cancer: a randomized phase 2 trial. Oncotarget. 2016 Sep 13;7(37):60647-60656. doi: 10.18632/oncotarget.10607.

  PMID: 27447966 BACKGROUND

• Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.

  PMID: 25092775 BACKGROUND

• Kumar P, Aggarwal R. An overview of triple-negative breast cancer. Arch Gynecol Obstet. 2016 Feb;293(2):247-69. doi: 10.1007/s00404-015-3859-y. Epub 2015 Sep 4.

  PMID: 26341644 BACKGROUND

• Dent R, Trudeau M, Pritchard KI, Hanna WM, Kahn HK, Sawka CA, Lickley LA, Rawlinson E, Sun P, Narod SA. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34. doi: 10.1158/1078-0432.CCR-06-3045.

  PMID: 17671126 BACKGROUND

• Jin J, Zhang W, Ji W, Yang F, Guan X. Predictive biomarkers for triple negative breast cancer treated with platinum-based chemotherapy. Cancer Biol Ther. 2017 Jun 3;18(6):369-378. doi: 10.1080/15384047.2017.1323582. Epub 2017 May 11.

  PMID: 28494179 BACKGROUND

• Lips EH, Mulder L, Oonk A, van der Kolk LE, Hogervorst FB, Imholz AL, Wesseling J, Rodenhuis S, Nederlof PM. Triple-negative breast cancer: BRCAness and concordance of clinical features with BRCA1-mutation carriers. Br J Cancer. 2013 May 28;108(10):2172-7. doi: 10.1038/bjc.2013.144. Epub 2013 Apr 4.

  PMID: 23558900 BACKGROUND

• Prat A, Cruz C, Hoadley KA, Diez O, Perou CM, Balmana J. Molecular features of the basal-like breast cancer subtype based on BRCA1 mutation status. Breast Cancer Res Treat. 2014 Aug;147(1):185-91. doi: 10.1007/s10549-014-3056-x. Epub 2014 Jul 22.

  PMID: 25048467 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Telli ML, Hellyer J, Audeh W, Jensen KC, Bose S, Timms KM, Gutin A, Abkevich V, Peterson RN, Neff C, Hughes E, Sangale Z, Jones J, Hartman AR, Chang PJ, Vinayak S, Wenstrup R, Ford JM. Homologous recombination deficiency (HRD) status predicts response to standard neoadjuvant chemotherapy in patients with triple-negative or BRCA1/2 mutation-associated breast cancer. Breast Cancer Res Treat. 2018 Apr;168(3):625-630. doi: 10.1007/s10549-017-4624-7. Epub 2017 Dec 23.

  PMID: 29275435 BACKGROUND

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Doxorubicin; Cyclophosphamide; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Mohammad J Shams, MBBS, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad J Shams, MBBS, MD

CONTACT

+8801911177774; jsnitol@gmail.com

Sajib K Talukdhar, MBBS, MD

CONTACT

+8801723620231; sajibkumar@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer, Department of Clinical Oncology

Model Details: This is a double-blinded randomized controlled trial to explore the efficacy and toxicity of platinum-based versus non-platinum-based neoadjuvant chemotherapy in triple-negative breast cancer.

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 24, 2023
• Study Start: June 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)