NCT02514681: PRECIOUS

A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer

Completed Phase 3 Last updated 10 September 2025

What this trial tests

Phase 3 trial testing Trastuzumab in HER2-positive Locally Advanced or Metastatic Breast Cancer in 226 participants. Completed in 10 August 2022.

Timeline

1 August 2015

Primary endpoint
31 December 2018

10 August 2022

Quick facts

Lead sponsor	Japan Breast Cancer Research Group
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	226
Start date	1 August 2015
Primary completion	31 December 2018
Estimated completion	10 August 2022
Sites	3 locations across Japan

Drugs / interventions tested

• Trastuzumab (trastuzumab) — full drug profile →
• Pertuzumab
• Docetaxel
• Paclitaxel — full drug profile →
• Nab-paclitaxel
• Vinorelbine
• Eribulin (ERIBULIN) — full drug profile →
• Capecitabine (capecitabine) — full drug profile →
• Gemcitabine

Conditions studied

• HER2-positive Locally Advanced or Metastatic Breast Cancer — all drugs for HER2-positive Locally Advanced or Metastatic Breast Cancer →

Sponsor

Japan Breast Cancer Research Group

Who can join

20 and older, female only, with HER2-positive Locally Advanced or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer patients for previously treated with pertuzumab

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. microRNA-based diagnostic and therapeutic applications in cancer medicine.
   Sempere LF, Azmi AS, Moore A. · · 2021 · cited 97× · PMID 33998154 · DOI 10.1002/wrna.1662
2. Extracellular vesicles as cancer liquid biopsies: from discovery, validation, to clinical application.
   Zhao Z, Fan J, Hsu YS, Lyon CJ, et al · · 2019 · cited 79× · PMID 30882822 · DOI 10.1039/c8lc01123k
3. Emerging Role of Extracellular Vesicles and Cellular Communication in Metastasis.
   Forder A, Hsing CY, Trejo Vazquez J, Garnis C. · · 2021 · cited 38× · PMID 34943937 · DOI 10.3390/cells10123429
4. The Effectiveness of Cancer Immune Checkpoint Inhibitor Retreatment and Rechallenge-A Systematic Review.
   Perdyan A, Sobocki BK, Balihodzic A, Dąbrowska A, et al · · 2023 · cited 26× · PMID 37444600 · DOI 10.3390/cancers15133490
5. Current and future landscape of targeted therapy in HER2-positive advanced breast cancer: redrawing the lines.
   Simmons C, Rayson D, Joy AA, Henning JW, et al · · 2022 · cited 21× · PMID 35035535 · DOI 10.1177/17588359211066677
6. Pertuzumab retreatment for HER2-positive advanced breast cancer: A randomized, open-label phase III study (PRECIOUS).
   Yamamoto Y, Iwata H, Taira N, Masuda N, et al · · 2022 · cited 13× · PMID 35754298 · DOI 10.1111/cas.15474
7. Current challenges and unmet needs in treating patients with human epidermal growth factor receptor 2-positive advanced breast cancer.
   Aapro M, Cardoso F, Curigliano G, Eniu A, et al · · 2022 · cited 9× · PMID 36279803 · DOI 10.1016/j.breast.2022.07.011
8. Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917).
   Nakayama T, Yoshinami T, Yasojima H, Kittaka N, et al · · 2021 · cited 6× · PMID 34238257 · DOI 10.1186/s12885-021-08504-1