NCT00929591

Phase III Comparison of Adjuvant Chemoendocrine Therapy With CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients With Involved Axillary Lymph Nodes and Positive Receptors

Completed Phase 3 Last updated 23 January 2013

What this trial tests

Phase 3 trial testing cyclophosphamide in Breast Cancer in 1,558 participants. Completed in 1 March 2010.

Timeline

1 May 1989

Primary endpoint
1 August 2005

1 March 2010

Quick facts

Lead sponsor	SWOG Cancer Research Network
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,558
Start date	1 May 1989
Primary completion	1 August 2005
Estimated completion	1 March 2010

Drugs / interventions tested

• cyclophosphamide (cyclophosphamide) — full drug profile →
• doxorubicin hydrochloride — full drug profile →
• endocrine therapy
• endocrine-modulating drug therapy
• fluorouracil — full drug profile →
• tamoxifen citrate
• brachytherapy
• low-LET electron therapy
• low-LET photon therapy
• radiation therapy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

SWOG Cancer Research Network

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease-free survival
  Time frame: eight years
• Overall survival
  Time frame: eight years
• Toxicity/morbidity of treatment
  Time frame: during treatment

Sponsor's own description

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen alone is more effective in treating breast cancer than giving tamoxifen together with chemotherapy or after chemotherapy.

PURPOSE: This randomized phase III trial is studying giving tamoxifen with or without combination chemotherapy to compare how well they work in treating postmenopausal women who have undergone surgery for breast cancer.

Publications & conference data

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

1. Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomised controlled trial.
   Albain KS, Barlow WE, Ravdin PM, Farrar WB, et al · · 2009 · cited 172× · PMID 20004966 · DOI 10.1016/s0140-6736(09)61523-3
2. Evaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial.
   Speers CW, Symmans WF, Barlow WE, Trevarton A, et al · · 2023 · cited 13× · PMID 36649570 · DOI 10.1200/jco.22.01499
3. Adjusting for covariates in evaluating markers for selecting treatment, with application to guiding chemotherapy for treating estrogen-receptor-positive, node-positive breast cancer.
   Janes H, Brown MD, Crager MR, Miller DP, et al · · 2017 · cited 5× · PMID 28818434 · DOI 10.1016/j.cct.2017.08.004
4. Design and analysis considerations for investigating patient subgroups of interest within cancer clinical trials.
   Mazza GL, Culakova E, Enserro DM, Dignam JJ, et al · · 2025 · cited 1× · PMID 39989043 · DOI 10.1093/jncimonographs/lgae045